One Minute With Dr. Mark Stengler | Testosterone Replacement Therapy
http://markstengler.com facebook.com/markstengler Watch naturopathic doctor Mark Stengler, N.M.D.talk about natural hormone replacement therapy (specifically...
By: Mark Stengler
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One Minute With Dr. Mark Stengler | Testosterone Replacement Therapy - Video
Why bother to take nutrients that boost testosterone? Why not take testosterone directly?
The short answer is:
testosterone replacement therapy (TRT) can be extremely hazardous to your health. Its much safer to attain higher T levels by taking nutrients proven to boost testosterone production naturally within the human body than to consume the hormone
Heres the story
Testosterone replacement therapy is the intake of testosterone directly into your body where it then enters the bloodstream. The forms of TRT include injections, patches, gels, and pills. TRT was first made available as a patch, but it caused skin irritation in as many as one out of four men who wore the patches.
Men who used testosterone gel were warned to wash their hands after application and not allow anyone to touch them on the skin where the gel was applied. Reason: If a woman or child comes in contact with testosterone gel, it can cause side effects including hair growth and premature puberty.
Oral testosterone is available in Canada and Europe, but not in the U.S., where it is banned because directly ingesting testosterone can cause liver toxicity. The FDA classifies testosterone as a controlled substance, so it is more tightly regulated than vitamins and minerals.
Another mode of oral testosterone therapy, Striant, comes in a tablet that is applied to the upper gums. While it is more effective than patches at boosting testosterone levels, Striant can cause gum or mouth irritation, pain, and tenderness. Again, care must be taken to ensure no woman or child comes in contact with the hormone.
But the prognosis for using TRT to boost declining testosterone levels gets worse. To begin with, testosterone therapy can elevate your red blood cell count. This in turn can thicken the blood, putting you at greater risk for stroke and heart attack. A study published in the Journal of the American Medical Association (JAMA) examined 1,223 men with low testosterone levels who were about 60 years old.
The JAMA study found that those men in the group who took testosterone replacement therapy had a 30% increase in risk of stroke and heart attack vs. men in the group who did not do TRT. Other side effects of testosterone therapy can include sleep apnea, acne, and gynecomastia male breast enlargement.
While there is little evidence of any link between testosterone therapy and prostate cancer, some physicians believe the issue is still on the table and urge patients getting TRT to check their PSA levels once or twice a year.
Another study, published in the New England Journal of American, examined the effect of testosterone gel in men 65 and older. It was discontinued when participants experienced cardiac, respiratory, and skin problems. Many did, however, experience an increase in muscle strength before the study was halted.
Heres the worst thing about TRT: using a testosterone patch, pill, gel, or injection for even just a couple of weeks can shut down the natural testosterone-producing actions of your pituitary gland, hypothalamus, and gonads. Your body stops making testosterone, and your testicles decrease in size. And the longer you stay on testosterone replacement therapy, the more difficult it is for your body to resume natural testosterone production should you ever stop using TRT. Yikes!
So what are we to conclude?
Countless clinical studies prove that low testosterone has many adverse effects including muscle loss, weight gain, low libido, irritability, fatigue, and mental decline. And, starting at around age 30, your testosterone levels decline with each passing year.
Yet reversing the decline by taking testosterone directly either ingesting it as a pill, through injection, or by applying a gel or patch is downright dangerous, risking liver toxicity, stroke, heart attack, and other ills.
The solution: Make some nutritional, exercise, and other lifestyle changes that can elevate your testosterone levels naturally. Take healthy nutrients herbs, amino acids, minerals, vitamins that trigger your body to produce new testosterone as nature intended.
And remember: only PrimeMale gives you the optimal dosages of the 12 key nutrients that in combination can quickly replenish your testosterone levels giving you all the male hormone you need to function at peak efficiency.
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Why You Should Never, Ever Treat Low Testosterone with ...
Jury finds drugmaker responsible for fraudulent misrepresentation
Payday
An Illinois jury handed plaintiffs $150 million in a case against AbbVie Inc. and Abbott Labs. Jesse Mitchell and his wife, Kimberly, an Oregon couple, sued the defendants after the companies testosterone replacement drug AndroGel allegedly caused Jesses severe heart problems. Mitchell claims that he decided to try AndroGel after seeing advertisements for the drug. Upon receiving a prescription from his doctor, he used it from 2008 until 2012, when his heart problems began.
Bellwether
The Mitchellscomplaint, filed in November 2014, is one of more than 7,000 brought by consumers alleging that widely marketed low-testosterone therapies led to harmful cardiac-related side effects. In 2014 the lawsuits, which include cases against Besins and Eli Lilly, were consolidated into a multi-district litigation (MDL) in the Northern District of Illinois. The Mitchells case against AbbVie is one of a handful of bellwether cases involving the drugmaker that have been identified by the court.
Common to the AbbVie cases is the accusation that the company engaged in misleading ads that preyed on the hopes and fears of middle-aged men. The advertisements included suspect tests for Low T, which lumped in the normal effects of aging with symptoms of actual low-testosterone disorders.
One Out of Three
The Mitchells specifically alleged that AbbVie failed to warn consumers of the dangers of using AndroGel and that the design of the drug was defective and unreasonably dangerous. They also accused AbbVie of negligence, fraud and negligent misrepresentation, seeking a variety of damages, injunctive relief and attorneys fees. At trial, their attorneys urged legal theories of strict liability, negligence and fraudulent misrepresentation.
The jury let AbbVie off the hook for the first two claims, failing to find that AbbVies conduct caused Mitchells medical woes. On the third count, the jury held the drugmaker liable for fraudulent misrepresentation related to the advertising campaigns launched by the company.
The Takeaway
Courts find bellwether cases to be a helpful tool for spotting and resolving certain issues common to a large number of lawsuits. The Mitchells case, along with the other low-testosterone bellwethers, will have an impact on the fate of the remaining litigation in the MDL.
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AbbVie Hit With $150 Million Loss in Low-T Cardiac Trial - Lexology (registration)
Glory heavyweight champion Rico Verhoeven will return to the ring in a non-title bout on Oct. 14 in Gangzhou, China, taking on former UFC fighter Antonio Silva, but fans didnt seem to approve the match-up.
Bigfoot" was knocked out seven times over the past four years, winning only one of his last 10 MMA bouts, and never competed in a kickboxing fight before. Verhoeven, on the other hand, holds a 51-10-1 kickboxing record with wins over the likes of Badr Hari, Peter Aerts, Gokhan Saki and Sergei Kharitonov.
"Critics will always exist and we have to know how to deal with them, Silva told MMA Fighting. "Sometimes they dont even mean to criticize you, but they are just jealous they wanted to be a professional fighter and dont have that talent. I was always a humble person, I came from a humble family in Paraba and competed around the world, and some people dont accept that.
"Its a heavyweight fight and anything can happen. I respect Rico, he's the champion, but when I step into the ring anything can happen."
The criticism is not of Silva taking a fight against the champion, but toward the promotion for booking someone who has been knocked out many times recently against the best heavyweight kickboxer on the planet.
Asked if someone in his team was against the match-up for health reasons, Silva said it was quite the opposite.
"As soon as we received the offer, everyone was in favor of it, "Bigfoot" said. "My manager, Alex Davis, said it was a good fight because he knows me and knows I can go there and put on a good fight. Everyone supported me because the impossible doesnt exist. If you go in there thinking that you cant do it, that hes the No. 1, or if you go there for the money, you already lost. I dont think like that. Im not going there for money or media, Im going there because I know I can put on a good fight."
"I went five rounds with Mark Hunt, and we stood and fought for 22 minutes. I knocked out (Alistair) Overeem, a K-1 champion, he continued. "Every athlete has to be versatile. I started in karate, but I always trained everything. Not having to worry about getting taken down or being pressed against the cage makes the camp and the actual fight easier."
Silva started his camp three weeks ago, as soon as he was offered the fight, and is excited about the challenge.
"Its a new experience for me, he said. "Im a professional athlete for years and I like to try new things, new challenges. I feel like an amateur going for his first fight, trying to show what he can do, and God willing everything will be alright.
The Brazilian heavyweight started in martial arts in karate, training for 12 years until he turned 17 and decided to add jiu-jitsu to his game. Now, he says, I train muay thai and boxing four times a week."
For his kickboxing debut, Bigfoot" will move his camp to his hometown Brasilia, Brazil, to train with UFC veteran Guto Inocente, a second-degree kickboxing black belt who holds a 34-8 kickboxing record, 5-1 under the Glory banner. Silva also invited Pedro Rizzo to join his camp in Brasilia.
"Rico is the champion, he deserves a lot of respect, Silva said. "Hes the best heavyweight kickboxer in the world. Im an amateur, its my first kickboxing fight, and I want to show what I can do. I have nothing to prove, I have no responsibility. Rico has the responsibility, hes the champion. The pressure is on him. Im cool."
The 37-year-old heavyweight compares his Glory debut to Conor McGregors upcoming clash with boxing legend Floyd Mayweather, when the UFC lightweight champion steps into the boxing ring for the first time against a 49-0 professional boxer in Las Vegas.
"Its a similar situation, Silva said. "McGregor never boxed and is going there to try to surprise. He has no pressure over himself because 99 percent of the people bet on Mayweather. Hes undefeated, 49-0, so most of the people think he will win. Its the same thing in this fight. But were two human beings stepping into a ring to fight. Anything can happen in a heavyweight fight, one hand can land and change the story."
"Im rooting for McGregor, he added. "He deserves respect. Hes a two-division champion in the UFC and is making history. Him as a person, he talks a lot, I dont consider him an idol, but he deserves respect. Anything can happen in this fight. Im rooting for him even though I think Mayweather will win because hes 49-0 and always trained that, so its complicated. But everything is possible."
According to Silva, hes getting paid "much more" in his recent fights compared to his previous bouts in the UFC, but thats not the only difference in this fight. The Brazilian heavyweight, who was only allowed to use testosterone replacement therapy once in the UFC against Mark Hunt, when he ended up testing positive for elevate testosterone levels restarted the treatment before his last MMA fight.
"My case is not for muscular gain or to enhance performance, but for health issues, said Silva, who lost his last fight to former Bellator heavyweight champion Vitaly Minakov in Russia. "I really need this in my life to be physically and mentally well. Ive fought in the UFC when my testosterone levels were at 77 three weeks before the fight. That's the level of a 90-year-old man. My levels were always low, 300, when someone at my age would be 800. I have doctors following me, making sure my levels are always at the normal range.
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'Bigfoot' Silva responds to criticism of Rico Verhoeven fight, compares it to Mayweather vs. McGregor - MMA Fighting
Clin Interv Aging. 2007 Dec; 2(4): 561566.
Published online 2007 Dec.
Geriatrics Research, Education, and Clinical Center, North Florida/South Georgia Veterans Health System, Gainesville, FL, USA
Despite intensive research on testosterone therapy for older men, important questions remain unanswered. The evidence clearly indicates that many older men display a partial androgen deficiency. In older men, low circulating testosterone is correlated with low muscle strength, with high adiposity, with insulin resistance and with poor cognitive performance. Testosterone replacement in older men has produced benefits, but not consistently so. The inconsistency may arise from differences in the dose and duration of testosterone treatment, as well as selection of the target population. Generally, studies reporting anabolic responses to testosterone have employed higher doses of testosterone for longer treatment periods and have targeted older men whose baseline circulating bioavailable testosterone levels were low. Most studies of testosterone replacement have reported anabolic that are modest compared to what can be achieved with resistance exercise training. However, several strategies currently under evaluation have the potential to produce greater anabolic effects and to do so in a safe manner. At this time, testosterone therapy can not be recommended for the general population of older men. Older men who are hypogonadal are at greater risk for the catabolic effects associated with a number of acute and chronic medical conditions. Future research is likely to reveal benefits of testosterone therapy for some of these special populations. Testosterone therapy produces a number of adverse effects, including worsening of sleep apnea, gynecomastia, polycythemia and elevation of PSA. Efficacy and adverse effects should be assessed frequently throughout the course of therapy.
Keywords: aging, testosterone, hypogonadism, physical function
In young adult men, the hypothalamic-pituitary-gonadal axis regulates the circulating concentration of testosterone. The hypothalamic pulse generator secretes a pulse of gonadotropin releasing hormone (GnRH) approximately every 90 minutes (Reyes-Fuentes and Veldhuis 1993). GnRH is secreted into the hypothalamic-pituitary portal circulation where it stimulates pituitary secretion of luteinizing hormone (LH) (Veldhuis et al 1990) into the systemic circulation. LH reaches the testes and promotes both tonic and episodic Leydig cell secretion of testosterone.
Nearly all of the testosterone circulating in the blood is bound to sex hormone-binding globulin (SHBG) or albumin. The affinity of SHBG for testosterone is about 1,000-fold higher than the affinity of albumin for testosterone (Pardridge et al 1985). Thus the combined free (1%2%) and albumin-bound fractions of testosterone are considered to be bioavailable (Manni et al 1985). Bioavailable testosterone in acts upon multiple target tissues and completes the feedback loop inhibiting GnRH and LH secretion.
The serum testosterone concentration displays both circadian and ultradian rhythms. The circadian rhythm results in peak testosterone serum concentrations during the early morning hours. In contrast, the ultradian rhythm has a cycle whereby the serum testosterone concentration fluctuates approximately every 90 minutes. This ultradian rhythm represents the burst-like secretory pattern of testosterone, which is superimposed on testosterones basal or tonic secretion.
In young adult health, the feedforward (GnRH stimulates LH which stimulates testosterone secretion) and feedback (free or bioavailable testosterone inhibits release of GnRH and LH) components of the hypothalamic-pituitary-gonadal axis maintain the serum total testosterone concentration within a normal range of 4501,000 ng/dL. The mean serum total testosterone concentration for healthy young adults approximates 650 ng/dL.
Unlike female menopause, the decline in testosterone serum concentration in men is gradual, and there is much inter-individual variability. Serum testosterone concentrations decline steadily after young adulthood, and by age of 80 years, the testosterone secretion rate decreases to approximately half that of a younger man (Tenover et al 1987; Mulligan et al 1995).
The decrease in bioavailable-testosterone appears to be greater than the decline in total testosterone with advancing age, due to an age-related increase in SHBG (Rubens et al 1974). The decline in testosterone with aging has been referred to by a variety of names including male menopause, climacteric, viropause, andropause, ADAM (androgen deficiency in aging men), or age-associated hypogonadism. Longitudinal studies confirm a decline in testosterone with aging, as has been reported earlier in cross-sectional studies (Morley et al 1997; Feldman et al 2002).
With age, changes that contribute to hypogonadism occur in both the hypothalamus and testes. The rise in LH following a decrease in testosterone is considerably blunted with age (Korenman et al 1990; Veldhuis et al 2001). This is likely due to failure of the hypothalamus to generate an appropriate burst of GnRH secretion (Veldhuis et al 1994; Mulligan et al 1999). The specific mechanism may be an age-related increased sensitivity of the hypothalamic-pituitary unit to the negative feedback effect of testosterone (Winters et al 1984). In older men, the decline in circulating testosterone also correlates with changes in the testes, specifically a decline in Leydig cell number (Neaves et al 1984), development of vacuolizations and lipofuscin within the Leydig cells, and decreased Leydig cell secretion of testosterone in response to provocative stimulation with human chorionic gonadotrophin (Harman and Tsitouras 1980).
The decline in bioavailable testosterone may be at least partially responsible for the decreased muscle mass, osteoporosis, mood disturbances, and frailty seen in older men (Nunez 1982).
The criteria for low testosterone are the same regardless of age. Symptomatic men with a total serum testosterone concentration less that 200 ng/dL are definitely hypogonadal, while those with a concentration between 200 and 300 ng/dL are probably hypogonadal. The prevalence of hypogonadism increases with advancing age; the odds ratio of hypogonadism is greater with each 10-year increase in age. Longitudinal studies in specific geographic areas of the United States and some small cross-sectional studies have demonstrated a decline in testosterone occurring as early as age 30, but usually testosterone levels remain within normal limits until men reach age 60 (Belanger et al 1994; Morley et al 1997). The prevalence of low serum total testosterone among men aged 45 years or older has been estimated to be 39% (Mulligan et al 2006). The prevalence of symptomatic hypogonadism is considerably lower, estimated as 6%12% in a group of men aged 4060 years in the report of the Massachusetts Male Aging Study (Araujo et al 2004).
Low serum testosterone concentration in older men is associated with depression (Shores et al 2005). However, most trials of testosterone replacement have not shown improvement in depression. Two small studies in younger hypogonadal men did show short term improvement in depression with testosterone supplementation, but this effect has not been reproduced in older men (Pope et al 2003). The age of onset of depression may also be a factor in response to testosterone. Perry et al (2002) reported that 6 weeks of testosterone treatment improved depression scores in men who had onset of depression after the age of 45 years, but not in men whose depression started at a younger age.
Higher bioavailable testosterone levels are associated with better performance in cognitive tests (Barett-Connor et al 2004). Short-term trials in healthy eugonadal older men have shown improvement in verbal and spatial memory (Cherrier et al 2001; Gray et al 2005). However, longer trials have produced mixed results. Haren et al (2005) reported no improvement in cognition or memory. In a recent study by Cherrier et al (2006), older men were treated for 6 weeks with testosterone at doses of 50, 100 or 300 mg/week. Interestingly, improvements in verbal and spatial memory were observed only with the intermediate dose.
Testosterone produces substantial anabolic effects in young and middle-aged hypogonadal men (Bhasin et al 2001). In contrast, the anabolic effects of testosterone replacement therapy in older men have been harder to demonstrate. Among the many published trials of testosterone in older men, some report strength gains and some do not. Only a few report strength gains that can be considered substantial in comparison to the benefits of resistance exercise training. In most cases, the studies reporting significant strength gains were performed in hypogonadal subjects and employed a higher dose of testosterone, for a longer duration.
In a recent report, Nair et al (2006) describe treating a group of hypogonadal men for 24 months with a transdermal testosterone at a dose of 35 mg/week and finding no increase in strength. However, 35 mg/week is less than a replacement dose and resulted in only a 30% increase in the circulating testosterone concentration. Studies by Brill et al (2002), Clague et al (1999), Kenny et al (2001), and Snyder et al (1999) also report small increases in strength. Brill et al treated older men for 1 month with 5 mg testosterone/day by patch and found an improvement in stair climb time, but no increase in strength. Clague et al treated men aged 60 or more with total T of 400 ng/dL or less were treated with 200 mg testosterone enanthate every two weeks by i.m. injection for 3 months and found no significant increase in strength. Kenny et al (2001) treated hypogonadal and low-normal older men with 5 mg testosterone/day by patch for 1 year and found a 38% increase in strength with testosterone, but surprisingly also a 27% increase with placebo, with no significant difference between the two groups. Snyder et al (1999) treated older hypogonadal and eugonadal men for 36 months with 6 mg testosterone/day by patch and found no increase in strength.
Several investigators have reported that testosterone caused moderate increases in strength; increases that are significant, but are still below than what can be obtained through resistance exercise training. Wang et al (2000) treated younger and older men (aged 1968) with total T of 300 ng/dL or less with a titrated dose of testosterone gel (equivalent of 5 to 10 mg per day) for 6 months found that the higher dose caused, a reduction in negative moods, a sizable increase in hematocrit (from 42 to 47), and modest increases in arm and leg strength. Sullivan et al (2005) conducted a 3-month study of low- or high-intensity resistance exercise training in men aged 65 or more, who were not hypogonadal (total T = 480 ng/dL or less). Some subjects also received a weekly i.m. injection of 100 mg testosterone enanthate. The addition of testosterone produced a trend toward greater increases overall, but the effect of testosterone appears to be substantial in the low-intensity training group. Considering that few men in the community will perform high-intensity training on their own, these results may indicate usefulness for testosterone therapy.
Three studies have reported substantial strength gains following testosterone treatment and all have employed doses of testosterone that are somewhat higher than replacement doses. Ferrando et al (2002) treated older hypogonadal and eugonadal men for 6 months with a biweekly injection of testosterone that was titrated to raises circulating testosterone into the normal range and resulted in an approximated doubling of circulating testosterone (from 300 to 600 ng/dL). Significant strength increases were observed, including a 15 kg increase in leg extension 1-RM strength. Page et al (2005) treated a group of older, hypogonadal men for 36 months with biweekly i.m. injections of 200 mg testosterone enanthate and found significant improvements in hand grip strength. However, the study that best demonstrates the dose dependence is that of Bhasin et al (2005). Both older and younger men were first made hypogonadal with luprolide and then treated for 5 months with testosterone enanthate at doses ranging from 25 mg to 600 mg/week. Higher doses of testosterone produced large increases in strength, including an increase of 50 kg in leg press 1-RM strength in older men receiving a dose of 300 mg/week. The doses of 300 and 600 mg/week produced a high incidence of adverse effects and a dose of 125 mg/week was considered to be the best trade-off of beneficial and adverse effects.
The dose of testosterone also appears to be critical in determining whether increases in bone mineral density are observed. Snyder et al (1999) treated older hypogonadal and eugonadal men for 36 months with 6 mg testosterone/day by patch and found that bone mineral density did not increase overall, but did do so in the group with the lowest pretreatment testosterone levels. However, Amory et al (2004) treated older hypogonadal men for 36 months with biweekly i.m. injections of 200 mg testosterone enanthate and obtained substantial increases in bone mineral density, 3%4% in the hip and a remarkable 10% in the lumbar spine.
The lower rate of heart disease in women has historically been attributed to the cardioprotective effects of estrogen. Presently, this position is being reexamined. The cardioprotective effects of estrogen have come into some question and there is emerging evidence that testosterone may have cardioprotective effects of its own. Swartz and Young (1987) have shown that older men with a low circulating testosterone, a higher fraction have previously suffered a myocardial infarction. Testosterone supplementation in hypogonadal men improves exercise tolerance and decreases exercise-associated ischemia in elderly patients with coronary artery disease and low (Malkin et al 2004) or low-normal (English et al 2000) testosterone. This protection may be secondary to a vasodilatory effect and/or higher pain threshold. The vasodilatory effect has been confirmed in animal models (English et al 2002). The beneficial effects are seen with both acute (Rosano et al 1999) and chronic (English et al 2000, 2002) testosterone administration, and also with low (Malkin et al 2004) and high (Rosano et al 1999) dose supplementation. However, none of these studies was long enough to show an effect on cardiovascular mortality.
Although there has been concern that testosterone therapy might adversely affect serum cholesterol and lipids, this concern has not been bourn out in controlled studies. Wang et al (2000) reported that treating hypogonadal men with testosterone gel (equivalent of 510 mg per day) for 6 months did not produce significant changes in LDL- or HDL-cholesterol. Whitsel et al (2001) performed a meta analysis of 19 studies involving administration of testosterone esters to older hypogonadal men and found that, on the whole, testosterone produces small, and probably offsetting, decreases in both HDL and LDL. An additional cardiac benefit of testosterone may be seen in the findings of Malkin et al (2004), who found that testosterone reduced circulating levels of tumor necrosis factor alpha and interleukin-1 beta, inflammatory cytokines that are elevated in heart failure.
Risks associated with testosterone replacement in elderly men include fluid retention, gynecomastia, worsening of sleep apnea, polycythemia and acceleration of benign or malignant prostatic disease (Matsumoto 2002). A high incidence of adverse effects was observed by Bhasin et al (2005) in treating older men with the very high doses of 300 and 600 mg/week.
Among these risks, the potential effects of testosterone on the prostate are of the greatest concern. These concerns stem from the known action of testosterone in accelerating active prostate cancer and from the high prevalence of early-stage prostate cancer in elderly men. While approximately 10% of men will develop clinically manifest prostate cancer in their lifetime and 3% will die of the disease, autopsy data show that 42% of men over the age of 60 have early-stage prostate cancer (Mikuz 1997). Clinical trials to date are not large enough or long enough to determine the potential effects of testosterone treatment on prostate cancer. Although Zitzmann et al (2003) have shown that replacement and slightly higher doses of testosterone produce a predictable and moderate degree of prostate enlargement, existing data do not indicate that testosterone promotes prostate cancer. Hajjar et al (1997) treated elderly men with a replacement dose of testosterone and found no increase in prostate cancer during a 2-year follow-up. Agarwal and Oefelein (2005) administered testosterone for 19 months to hypogonadal patients with a history of prostate cancer and prostatectomy, but whose recent PSA levels were low. Treatment significantly elevated circulating testosterone and improved quality of life without elevating PSA.
Patients should be evaluated one month after initiation of treatment and the dose should be increased if symptoms of hypogonadism have not improved. Rhoden and Morgentaler (2004) have reviewed the adverse effects and recommend the following monitoring. Safety monitoring should include sleep apnea, voiding symptoms, serum testosterone, PSA and hemoglobin or hematocrit and should be performed several times during the first year and yearly thereafter.
In response to concerns over the efficacy and risks of hormonal replacement in the elderly, the NIH commissioned an assessment by the Institute of Medicine (IOM). The IOM report states that there is insufficient evidence to conclude that testosterone treatment in older men has well established benefits. In addition, the IOM recommended that small and medium-sized trials be conducted to assess the efficacy of testosterone for treating muscle weakness, osteoporosis, sexual dysfunction, cognitive impairment and depression (Liverman and Blazer 2004). The IOM does not recommend prevention trials or trials for all hypogonadal older men. While we agree with these recommendations, at least two other avenues of exploration deserve attention.
First, while replacement doses of testosterone do not consistently produce substantial increases in strength, Page et al (2005) and Bhasin et al (2005) have shown that higher doses of testosterone do produce such increases. Higher doses of testosterone also produce more adverse effects, especially prostate effects. Strength, especially lower body strength, remains an important facto limiting the independence of older people. Currently, alternative strategies are being developed, aimed at stimulating the androgen receptor more powerfully, without producing added adverse effects. One such strategy is to administer a higher dose of testosterone with the addition of a 5-alpha reductase inhibitor to prevent the prostate symptoms. Another strategy is the use of selective androgen receptor modulators (SARMs), currently under development at several pharmaceutical firms.
A second avenue where more research is needed is testosterone therapy for special populations of men who are at risk for development of catabolic states and muscle wasting. Testosterone might be used to prevent disuse muscle atrophy following knee or hip replacement. A study by Amory et al (2002) suggests that treating men with testosterone before knee replacement surgery improved functional independence after. While these results were not dramatic, one limitation of the study is that testosterone therapy did not continue after surgery, ie, during the period of muscle atrophy. In addition, hypogonadism and muscle wasting are associated with a number of conditions that are more common in older men including COPD (Debigare et al 2003), coronary artery disease (Rosano et al 2006), glucocorticoid therapy (Salehian and Kejriwal 1999), and acute ischemic stoke (Jeppesen et al 1996). It is likely that in some cases, testosterone therapy may prevent catabolic/muscle wasting syndromes associated with these conditions.
In conclusion, while it is true that most studies of testosterone replacement in older men have not produced substantial increases in strength, testosterone therapy continues to hold promise for older men. Testosterone may be of greater use in special populations who are at risk for development of a catabolic state (eg, patients recovering from a long period of bed rest or joint replacement). In addition, there is promise that strategies will be developed to stimulate the testosterone pathway more robustly and to do so in a safe manner. If so, there may be indication for use of such therapy in a broader segment of the population of older men. In the meantime, truly hypogonadal men (those who are symptomatic men and have a serum testosterone concentration below 200 ng/dL) who have no contraindications to testosterone replacement therapy (eg, prostate cancer) may benefit from testosterone replacement regardless of whether they are 30 or 80 years of age.
Articles from Clinical Interventions in Aging are provided here courtesy of Dove Press
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Stanley E. Rosenberg Urology Group Princeton PA 134 Stanhope St Princeton, NJ 08540 (609) 924-6487
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Barry R. Rossman Urology Group Princeton PA 134 Stanhope St Princeton, NJ 08540 (609) 924-6487
35
Karen M. Latzko Urology Group Princeton PA 134 Stanhope St Princeton, NJ 08540 (609) 924-6487
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Jamison S. Jaffe Comprehensive Urologic Specialists 1203 Langhorne Newtown Rd St Clare Bldg Ste 334 Langhorne, PA 19047 (215) 710-4490
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Laura Gurten Comprehensive Urologic Specialists 1203 Langhorne Newtown Rd St Clare Bldg Ste 334 Langhorne, PA 19047 (215) 710-4490
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Justin D. Harmon Comprehensive Urologic Specialists 1203 Langhorne Newtown Rd St Clare Bldg Ste 334 Langhorne, PA 19047 (215) 710-4490
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Stephanie M. Molden Female Pelvic Health Center 760 Newtown Yardley Rd Ste 115 Newtown, PA 18940 (215) 504-8900
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Manish Gopal Shore Area Obstetrics & Gynecology PA 111 Union Valley Rd Ste 202 Monroe, NJ 08831 (877) 987-6496
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Devdatta R. Gabale Urology Care Alliance 1205 Langhorne Newtown Rd Ste 104 Langhorne, PA 19047 (215) 757-6931
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Joel W. Goldsmith Robert Wood Johnson Medical Group Urology 1 Worlds Fair Dr FL 1 Somerset, NJ 08873 (732) 235-5642
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Emily Baliant Urology Care Alliance 333 Forsgate Dr Ste 202 Jamesburg, NJ 08831 (732) 561-2058
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Steven L. Richards Urology Care Alliance 333 Forsgate Dr Ste 202 Jamesburg, NJ 08831 (732) 561-2058
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Heather Gottlieb Urological Associates PC 3998 Red Lion Rd Ste 305 Philadelphia, PA 19114 (215) 632-8882
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Milton E. Coll Urological Associates PC 3998 Red Lion Rd Ste 305 Philadelphia, PA 19114 (215) 632-8882
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Jamie A. Gray Urological Associates PC 3998 Red Lion Rd Ste 305 Philadelphia, PA 19114 (215) 632-8882
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Joan E. Zaccardi Urogynecology Arts New Jersey 620 Cranbury Rd Ste 219 East Brunswick, NJ 08816 (732) 651-0005
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Mark L. Mokrzycki Urogynecology Arts New Jersey 620 Cranbury Rd Ste 219 East Brunswick, NJ 08816 (732) 651-0005
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Jeffrey I. Silverstein Atlantic Urology 495 Iron Bridge Rd Ste 11 Freehold, NJ 07728 (732) 683-1617
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Alexader Kirshebaum William I Kohlberg MD 501 Iron Bridge Rd Ste 5 Freehold, NJ 07728 (732) 780-7603
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Hamilton NJ Urologist Doctors - Testosterone Replacement ...
Low T Nation specializes in Mens Health education and care in the Greater Atlanta area. Our treatment specialties include managing the symptoms of Low Testosterone, Erectile Dysfunction, and Human Growth Hormone Management. We pride ourselves in our education efforts to ensure that every practitioner at Low T Nation is aware of all of the latest treatment and service breakthroughs . We utilizeincredibly well developed protocols and close medical supervision. Add in great communication practices, constant patient education and top notch pharmaceuticalsandour patients are as happy and healthy as possible at all times.
Atlanta Low Testosterone Therapy. We educate, evaluate and treat men with Low Testosterone using a very individualized and customized system of care. We qualify patients based on a number of symptomatic and labwork related criteria. Once a patient has met the basic qualifications, we check for health related disqualifying factors. If the patient is still a good candidate for the Low-T Therapy, we then educate the patient on certain aspects of program administration and care. At that point, we take the patient on as one of our own and the patient is under our medical supervision. With our program, our patients have unlimitedaccess to our doctors and labsat anytime it is needed and this never costs more than the membership rate.
Erectile Dysfunction Specialists in Atlanta. Our ED program is a very versatile and cutting edge program that consists of a vast array of medications that we use to customize a perfect-fit formula for eachindividual male patient. Our treatments consist of several oral options and also many injection based solutions for our more severely affected men. We train patients on how to administer the protocols safely and effectively and what to do when the achieved result might not be the desired one. Our patients on our Atlanta Erectile Dysfunction protocols usually come back saying that weve dramatically improved their lives in many ways. From enhanced and reformed relationships, to restored self esteem and confidence, we love the outcomes our men communicate back to us after joining our family.
Human Growth Hormone Atlanta. We can successfully and safely increase human growth hormone levels in our patients by utilizing a proprietary system of precursory bio-identical hormones that stimulate the patients body to produce as much human growth hormone as possible. This approach is FAR superior to prescribing actual HGH because most men who arent producing HGH actually still have the ability to produce it. The body stops producing HGH for a variety of reasons, but our therapy will restart the biological function and optimize it moving forward. This approach also eliminates all of the catastrophic physiologic dangers of over use of HGH. Abuse or over prescribing HGH will cause extreme and dangerous side effects, therefore it is absolutely imperative to use a program that truly understands these risks and prescribes responsibly.
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Atlanta Low Testosterone Replacement and Men's Health Clinic
Millions of American men use a prescription testosterone gel, patch, or injection to boost levels of the manly hormone. The ongoing marketing blitz promises that treating "low T" this way can make men feel more alert, energetic, mentally sharp, and sexually functional. However, legitimate safety concerns linger, as explained in the February 2014 issue of the Harvard Men's Health Watch.
"Because of the marketing, men have been flooded with information about the potential benefit of fixing low testosterone, but not with the potential costs," says Dr. Carl Pallais, an endocrinologist and assistant professor of medicine at Harvard Medical School. "Men should be much more mindful of the possible long-term complications."
Some studies have found that men taking testosterone have more cardiovascular problems, like heart attacks, strokes, and deaths from heart disease. Some physicians also have a lingering concern that testosterone therapy could stimulate the growth of prostate cancer cells. Yet the evidence is mixed, with some studies showing a lower cardiac risk with testosterone therapy and no apparent effect on prostate cancer.
In such uncertain times, men should take a cautious approach, Dr. Pallais says.
"I can't tell you for certain that taking testosterone raises the risk of heart problems and prostate cancer, or that it doesn't," Dr. Pallais says. "We need a large study with multiple thousands of men followed for many years to figure it out."
Until then, here are some tips for taking a cautious approach to testosterone therapy:
Read the full-length article: "Is testosterone therapy safe? Take a breath before you take the plunge"
February 1, 2014
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Is testosterone replacement therapy safe? Take a look at ...
Over the last ten years there has been a significant debate regarding the safety of Physician-Monitored Testosterone Replacement Therapy. The treatment is more popular today than it has ever been, but certain questions of safety have not been sufficiently resolved to promote the widespread use of the treatment. A collection of studies released in May, 2015 has brought us one step closer to that point.
One of the most important contemporary concerns associated with Testosterone Therapy is how the treatment affects the Prostate. There have been some concerns that Testosterone Treatment can negatively affect the prostate, and lead to an increased risk of Prostate Cancer. Bio-Identical Testosterone has been previously associated with the release of a chemical known as PSA, or Prostate-Specific Antigen. In patients with Prostate Cancer, PSA levels are abnormally high, and it was hypothesized that the elevated PSA levels associated with Testosterone Therapy could be related to increased Prostate Cancer risk. New research suggests that these PSA counts have been overstated, and that there is no significant correlation between Testosterone Levels and PSA Levels.
This did not, however, absolve Testosterone Therapy completely of Prostate Cancer Risk, and further study was needed. These four studies, combined, provide strong evidence that the use of Testosterone for Hormone Replacement Therapy has no significant effect upon prostate cancer risk.
The results of these studies will be revealed at the upcoming American Uroligical Associaton Conference.
Benefits of Testosterone for Male Patients with Low-T
These studies not only provide increased knowledge regarding the overall safety profile of Low-T Therapy, but they also provide more insight into the overall benefits of Testosterone Treatment for men suffering from Andropauseor Age-Associated Testosterone Deficiency.
How Does Testosterone Benefit Patients?
The following is a short list of ways that healthy Testosterone Levels Benefit Patients:
Increased Fertility The body produces sperm as a direct result of the influence of Testosterone. Men with Testosterone Deficiency are more likely to have issues with fertilitythe greater the deficiency, the lower the sexual potency.
Increased Libido In both men and women, Testosterone is the primary trigger for sexual desire. When Testosterone Levels are too low, this leads directly to a reduced sex drive and desire for sexual pleasure.
Enhanced Sexual Ability As Testosterone Levels decline, so does a mans ability to maintain a hard and healthy erection. Testosterone Deficiency leads to reduced sexual pleasure, and is one of the primary causes of Erectile Dysfunction. Many men benefit from Testosterone Therapy without the need for Erectile Dysfunction Pills such as Viagra and Cialis.
Improved Red Blood Cell Count Testosterone Deficiency is also associated with fatigue and lack of energy. This can possibly be the result of inhibited Red Blood Cell Count associated with Abnormally Low Testosterone Levels. The cardiovascular system uses Red Blood Cells to transport oxygen through the body and facilitate energy production. For certain patients, this increased production of Red Blood Cells is not necessary, and can be potentially problematic, in which case, blood donation, or other methods of relief, can easily be performed.
Enhanced Muscle Mass and Strength Testosterone is most notable not only for its effect upon sexual function, but because of its anabolic effects on the human body. Testosterone and other Steroids are often used and abused by professional athletes and weight lifters in order to improve their athletic performance, but this is not recommended, as the abuse of steroids can potentially have dangerous consequences. On the other hand, normalized Testosterone Levels are associated with healthy muscle mass and the promotion of strength. The decline in muscle mass and strength associated with Testosterone Deficiency is another contributor to the weakness and fatigue related to the condition.
Healthier Bodyfat Composition In addition to promoting strength, Testosterone also promotes a leaner body. Testosterone is anabolic, which not only means that it builds muscle mass, but it promotes energy consumption as well. This is one reason why men need more calories on-average per day than women. As Testosterone Production drops due to Andropause, the body loses metabolism, and this results in increased bodyfat, particularly around the midsection, which is associated with an increased risk of heart and cardiovascular issues such as heart attack, cardiovascular disease, and stroke.
Healthier Bone Density In both men and women, the presence of healthy Testosterone Levels keeps the bones strong. Testosterone Deficiency leads to a loss of bone mineral density that increases the risk of breaks, fractures, and osteoporosis. Women are more susceptible, and susceptible to this earlier, because their lower innate Testosterone Production leaves them with weaker, less dense bone structure.
Testosterone Deficiency not the Only Cause of Low-T Associated Symptoms
Before turning to Testosterone, it is important to realize that Testosterone Deficiency is a deep-rooted disorder which shares many similar characteristics with other medical conditions. Never start taking Testosterone without undergoing the blood work and physical necessary to establish a clinical need for treatment.
Low-T Safety and Efficacy Study Details:
Study One: Testosterone Improves Cardiovascular Health in Older Patients
One study was conducted with regard to evaluating the effectiveness and safety of Testosterone Therapy among elderly patients with Low-T. The long-term use of Testosterone has not been fully evaluated, and this is one of the first major studies to measure how safe the treatment is and how well it works when prescribed consistantly for more than ten years. Researchers from the United States (Boston) and Germany (Bremerhaven) corroborated for this study, and found that Physician-Prescribed Testosterone Therapy was beneficial with regard to a number of symptoms in geriatric men with Low-T. Researchers found that these patients had an overall reduced risk of heart-related complications.
This study used existing data collected in order to analyze 262 male patients with hypogonadism. These men took Intramuscular Testosterone once every three months for as long as eleven years. The following is a list of benefits that the patients experienced:
Study Two: Testosterone Relieves Erectile Dysfunction symptoms among Diabetic Men and Improves Metabolic Function.
The same researchers conducted a second study which specifically evaluated patients with Diabetes that used Testosterone Therapy. They discovered that the same benefits listed in the previous study also led to an increase in sexual function, and improved metabolism in these particularly at-risk patients. Along with other recent studies, there is a growing body of evidence that Low-T Therapy can be a useful tool in the armory against Type-2 Diabetes.
Dr. Khler, a lead researcher in these studies, is confident that Low-T Therapy with Testosterone Injections can be highly beneficial for many patients with unhealthy Testosterone Levels. Of course, the treatment wont be right for everyone, but he sees the potential for a huge number of people to benefit.
Study Three: Testosterone Therapy Associated with Reduced Risk of Cardiovascular Complications
A third study assesses the risk of heart attack and stroke associated with Testosterone Therapy among men sixty-five and older. What they discovered was that Testosterone Injection Treatments did not lead to enhanced odds of experiencing medical issues such as pulmonary embolism, stroke, or heart attack. The study was produced by scientists from the Baylor College of Medicine, and evaluated the medical records of men with untreated Low-T in comparison to men with Testosterone Deficiency that received Low-T Treatment. Two hundred patients were evaluated, separated into two the two mentioned groups.
What researchers discovered was that men that opted for Testosterone Therapy Treatment experienced improved mortality rates as compared to those that did not choose Low-T Therapy. On the other hand, Testosterone did not have any significant effect upon rates of Pulmonary Embolism or Heart Attack, for better or worse.
Study Four: Testosterone Therapy, PSA, and Prostate Cancer Risk
This fourth study has not been fully processed yet, but so far, evaluation shows that Testosterone Therapy Treatments do not appear to increase the chances of getting prostate cancer, nor do they necessarily lead to increased PSA-Count. The researchers in this study looked over the data of eighteen other studies, covering over five thousand cases of prostate cancer, and including almost twelve thousand controls. Researchers organized all patients by their Testosterone Levels, and discovered that the risk of a patient getting prostate cancer had no significant correlation with their underlying Testosterone Levels. This was true of both endogenous, natural Testosterone and clinically prescribed Testosterone Replacement.
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New studies show that Testosterone Therapy is prostate safe
Testicular cancer - Testosterone replacement therapy - yourprivates.org.uk
WARNING! This video contains images of nudity in a medical context. yourprivates.org.uk This film describes testicular cancer and testosterone replacement therapy.
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Testicular cancer - Testosterone replacement therapy - yourprivates.org.uk - Video
Should You Tell People You #39;re On TESTOSTERONE REPLACEMENT THERAPY? | ASK NOAH
A question I get all the time from guys starting Testosterone Replacement Therapy is wether or not they should tell other people about it. I try and weigh th...
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Should You Tell People You're On TESTOSTERONE REPLACEMENT THERAPY? | ASK NOAH - Video
New Orleans Testosterone Replacement
Watch this video to uncover two testosterone therapy clinics in New Orleans that offer multiple services for Men. You will also learn what the four most commonly used testosterone replacement...
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What NOT to Expect On TESTOSTERONE REPLACEMENT THERAPY
How to set yourself up for success before during the early stages of Testosterone Replacement Therapy. Many guys set their sites so high that no amount of Testosterone could ever satisfy...
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What NOT to Expect On TESTOSTERONE REPLACEMENT THERAPY - Video
A hormone in both men and women
Testosterone is a hormone found in humans, as well as in other animals. The testicles primarily make testosterone in men. Womens ovaries also make testosterone, though in much smaller amounts. Testosterone production starts to increase significantly during puberty, and begins to dip after age 30 or so.
Testosterone is most often associated with sex drive, and plays a vital role in sperm production. But it also affects bone and muscle mass, the way men store fat in the body, and even red blood cell production. A mans testosterone levels can also affect his mood.
Low levels of testosterone can produce a variety of symptoms in men, including:
While testosterone production naturally tapers off as a man ages, other factors can cause hormone levels to drop. Injury to the testicles and cancer treatments such as chemotherapy or radiation can adversely affect testosterone production. Chronic diseases and stress can also reduce testosterone production. Some of these diseases include:
A simple blood test can determine testosterone levels. There is a wide range of normal or healthy level of testosterone circulating in the bloodstream. The normal range of testosterone for men is between 250 and 1100 ng/dL for adult males, and between 8 and 60 ng/dL for adult females, according to the Mayo Clinic. Ask your doctor to test your testosterone levels if you have concerns about low testosterone (low T).
Unusually low testosterone levels could be a sign of pituitary gland problems. The pituitary gland sends a signaling hormone to the testicles to produce more testosterone. A low T test result could indicate that the pituitary gland isnt working properly. A young teen with low testosterone levels may simply be experiencing delayed puberty.
Moderately elevated testosterone levels in men tend to produce few noticeable symptoms. Boys with higher levels of testosterone may begin puberty earlier. Women with excessive testosterone may develop masculine features.
Abnormally high levels of testosterone could be the result of an adrenal gland disorder, or even cancer of the testes. High levels may also occur in less serious conditions. Congenital adrenal hyperplasia, which can affect males and females, is a rare but natural cause for elevated testosterone production. Your doctor may order other tests if your levels are exceedingly high.
Reduced testosterone production, a condition known as hypogonadism. This doesnt always require treatment. A low T test result should trigger a check of your prostate health and red blood cell production. Serious medical issues sometimes coincide with decreased testosterone production, and should be diagnosed and treated if necessary.
You may be a candidate for testosterone replacement therapy if low T is interfering with your health and quality of life. Artificial testosterone can be administered orally, through injections, or with gels or patches on the skin.
Replacement therapy may produce desired results, such as greater muscle mass and a stronger sex drive. However, the treatment does carry some side effects. Oily skin and fluid retention are common. The testicles may also shrink, and sperm production could decrease significantly. Some studies have found no greater risk of prostate cancer with testosterone replacement therapy, but it continues to be a topic of ongoing research.
Research shows little evidence of abnormal or unhealthy psychological changes in men receiving supervised testosterone therapy to treat their low T, according to a study in the journal Therapeutics and Clinical Risk Management.However, mental and physical risks are involved in self-administration of artificial testosterone. Anyone abusing synthetic testosterone, also known as anabolic steroids, may experience episodes of aggressive or violent behavior, along with physical side effects. Bodybuilders, athletes, or anyone who seeks to build muscle mass or achieve other benefits from artificial testosterone should be aware of these risks.
Testosterone is most commonly associated with sex drive in men. It also affects mental health, bone and muscle mass, fat storage, and red blood cell production. Abnormally low or high levels can affect a mans mental and physical health. Your doctor can check your testosterone levels with a simple blood test. Testosterone therapy is available to treat men with low levels of testosterone. If you have low T, ask your doctor if this type of therapy might benefit you.
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NEW YORK, NY / ACCESSWIRE / November 20, 2019 / Bronstein, Gewirtz & Grossman, LLC notifies investors that a class action lawsuit has been filed against Lipocine Inc. ("Lipocine" or the "Company") (LPCN) and certain of its officers, on behalf of shareholders who purchased Lipocine securities purchased between March 27, 2019, and November 8, 2019, both dates inclusive. Such investors are encouraged to join this case by visiting the firm's site:www.bgandg.com/lpcn.
This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1934.
The complaint alleges that throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (1) the results from Lipocine's clinical studies of TLANDO were insufficient to demonstrate the drug's efficacy; (2) accordingly, Lipocine's third NDA for TLANDO was highly likely to be found deficient by the FDA; and (3) as a result, the Company's public statements were materially false and misleading at all relevant times.
On November 11, 2019, Lipocine announced receipt of a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration regarding its New Drug Application for TLANDO, Lipocine's product candidate for testosterone replacement therapy. Lipocine advised investors, inter alia, that "[t]he CRL identified one deficiency stating the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations." On this news, Lipocine's stock price fell sharply during intraday trading on November 11, 2019.
If you wish to review a copy of the Complaint you can visit the firm's site: http://www.bgandg.com/lpcn or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss in Lipocine you have until January 14, 2020 to request that the Court appoint you as lead plaintiff. A lead plaintiff acts on behalf of all other class members in directing the litigation. The lead plaintiff can select a law firm of its choice. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.
Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm's expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.
Contact:
Bronstein, Gewirtz & Grossman, LLCPeretz Bronstein or Yael Hurwitz
212-697-6484 | info@bgandg.com
SOURCE: Bronstein, Gewirtz & Grossman, LLC
View source version on accesswire.com: https://www.accesswire.com/566989/INVESTOR-ALERT--Lipocine-Inc-LPCN--Bronstein-Gewirtz-Grossman-LLC-Notifies-Investors-of-Class-Action-and-Lead-Deadline-January-14-2020
Boca Raton Testosterone Replacement Clinics
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Lost Libido is Restored with Testosterone Replacement
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