Category Archives: Hypogonadism

Reading Time: < 1 minuteHypogonadism can occur for a number of reasons. Certain men have hypogonadism since birth while others may develop this condition later in life. Two types of hypogonadism are: Primary hypogonadism (testicular failure) - Low serum testosterone levels and gonadotropins (FSH, LH) above the normal range. Hypogonadotropic hypogonadism - Idiopathic gonadotropin or LHRH deficiency or pituitary - hypothalamic injury from tumors, trauma, or radiation. Characterized by low serum testosterone levels, but with gonadotropins in the normal or low range. Men develop testicular suppression with decreased libido, impotence, decreased ejaculate volume, loss of body and facial hair, weakness, fatigue and often anemia. … Read more »

Reading Time: 2 minutesNEW YORK, Sept. 29, 2014 /PRNewswire-USNewswire/ --Androxal(R) Second Pivotal Study from Repros Therapeutics Inc. (NASDAQ: RPRX) a development stage biopharmaceutical company, achieves superiority in top line analysis for both co-primary endpoints compared to marketed topical gel in the treatment of secondary hypogonadism. However, the conclusions of the FDA Advisory Panel that met on Wednesday, September 17, 2014, to discuss the appropriate population suited to testosterone replacement therapy (TRT), were not directly related to Androxal(R), since Androxal(R) is not a form of testosterone. The FDA panelists voted to recommend that testosterone replacement class label should be changed, narrowing the treatment option … Read more »

Reading Time: < 1 minuteMale hypogonadism pathophysiology By: dave cohen Go here to see the original: Male hypogonadism pathophysiology - Video … Read more »

Reading Time: < 1 minuteOn each valid NATESTO prescription or refill, we would like to offer a 5% discount. The patient is responsible for any balance remaining, and for reporting receipt of this coupon benefit. Offer only valid for male or female patients over age 30 who will pay out of pocket. Offer good only in USA and void where prohibited by law, taxed, or restricted. … Read more »

Reading Time: 2 minutesRepros Therapeutics Inc. ( RPRX ) announced it has completed enrollment for one of the two head-to-head studies on its secondary hypogonadism candidate, Androxal. The two identical, 17-week, double-blind studies will compare the safety and efficacy of Androxal with a testosterone replacement therapy (topical gel) and placebo in restoring and maintaining testicular function. The primary endpoint of the study is to find if Androxal is superior to both placebo and the topical gel based on normal testosterone levels and normal sperm concentrations achieved by patients. While the first study (ZA-305) enrolled 120 men, the second study (ZA-304) will also enroll … Read more »

Reading Time: < 1 minuteRepros Therapeutics Inc. said it was notified by the U.S. Food and Drug Administration that there isnt enough clinical information to hold a planned pre-investigational new drug application meeting in November. Its shares RPRX, -39.96% dropped 43% in premarket trade in response. The stock had already lost more than half its value through Thursdays close in the past 12 months. The company in September said it had been granted a type B, pre-investigational new-drug application meeting with the FDA in the first half of November, when Repros planned to seek guidance on its planned new drug application for Androxal for … Read more »

Reading Time: 4 minutesTestosterone deficiency is frequently seen in both men and women with HIV. Endocrine abnormalities, which can affect testosterone production, have long been recognized as a complication of HIV since the earliest days of the pandemic (although it has generally been associated with late stage disease). However, recent research has shown that nearly one out of every five men with HIV has documented testosterone deficiency, irrespective of CD4 count, viral load, or treatment status. Similarly, testosterone deficiency is seen in one in four HIV-positive women, most often in the context of severe, unexplained weight loss (HIV wasting). Testosterone is the steroid … Read more »

Reading Time: < 1 minuteHypogonadism can begin during fetal development, before puberty or during adulthood. Signs and symptoms depend on when the condition develops. If the body doesn't produce enough testosterone during fetal development, the result may be impaired growth of the external sex organs. Depending on when hypogonadism develops and how much testosterone is present, a child who is genetically male may be born with: Male hypogonadism may delay puberty or cause incomplete or lack of normal development. It can cause: In adult males, hypogonadism may alter certain masculine physical characteristics and impair normal reproductive function. Signs and symptoms may include: Hypogonadism can … Read more »

Reading Time: 2 minutesEndo Health Solutions ' ( ENDP ) top line has been under pressure over the past few quarters due to declining sales of its key drugs. Sales have been hurt by generic competition. Endo recorded sales of $584.9 million in the fourth quarter of 2013, down 22%. Soft sales of painkillers, Lidoderm and Opana ER hurt the top line. To combat the generic threat, Endo has been signing deals/making acquisitions and also looking to introduce new products. The recent approval of Endo's Aveed (a long-acting testosterone undecanoate injection) by the U.S. Food and Drug Administration (FDA) is a positive for … Read more »

Reading Time: 3 minutesPosted: 11 Oct 2012 by valsully Topics: androgel, hypogonadism, hypogonadism - male, male Details: My boyfriend and I almost split up because of his mood swings last year. He is not the same man that I fell in love with when he is on Androgel as he is when he is off of it... I don't know what to do... I don't want to leave him but, I don't know if I can take the major mood swings he is having. Is this normal and will it go away? I don't want to give up on the man I love … Read more »

Reading Time: 2 minutesINTRODUCTION Hypogonadism in a male refers to a decrease in either of the two major functions of the testes: sperm production or testosterone production. These abnormalities can result from disease of the testes (primary hypogonadism) or disease of the pituitary or hypothalamus (secondary hypogonadism). The use of testosterone to treat hypogonadism in adult men, primary or secondary, is reviewed here. The clinical manifestations and diagnosis of male hypogonadism, induction of spermatogenesis in men with secondary hypogonadism, and induction of puberty with testosterone are discussed elsewhere. (See "Clinical features and diagnosis of male hypogonadism" and "Induction of fertility in men with … Read more »

Reading Time: < 1 minuteRepros Therapeutics Inc. ( RPRX ) is expected to report third-quarter 2014 results on Nov 6. Let's see how things are shaping up for this announcement. Factors at Play Last quarter, the company had posted a negative earnings surprise of 2.7%. Being a clinical-stage biotech company, Repros will continue to face an increase in R&D expenditure. Since the company does not generate any product revenues yet, investor focus will remain on its pipeline, particularly the status of the new drug application for Androxal, which is slated for submission by year-end. Androxal is the company's most advanced candidate and is being … Read more »

Reading Time: 4 minutesThe hormone testosterone is responsible for numerous sex characteristics in men including the growth and development of the sex and reproductive organs. In addition to assisting with fat distribution, bone mass and deepening of the voice, testosterone also helps keep up energy levels, sex drive and fertility. As men age, their production of testosterone naturally begins to decline. However, some men may develop a testosterone deficiency during their life. This disorder is known as hypogonadism. What Is It? Hypogonadism is one of the main causes of male infertility. It is estimated that 13 million men in the United States alone … Read more »

Reading Time: 2 minutesHypogonadism is a medical term for a defect of the reproductive system which results in lack of function of the gonads (ovaries or testes). Hypogonadism may occur if the hypothalamic-pituitary-gonadal axis is interrupted at any level. Hypergonadotropic hypogonadism (primary hypogonadism) results if the gonad does not produce the amount of steroid sufficient to suppress secretion of LH and FSH at normal levels. Hypogonadism resulting from defects of the gonads is traditionally referred to as primary hypogonadism. Examples include Klinefelter syndrome and Turner syndrome. Hypogonadism resulting from hypothalamic or pituitary defects are termed secondary hypogonadism or central hypogonadism (referring to the … Read more »

Reading Time: 2 minutesEarly symptoms of low testosterone in men include low libido (sex drive). As levels become very low, sexual dysfunction (also called "erectile dysfunction (ED)" or "impotence") often develops. Other signs and symptoms of low testosterone may include depression, fatigue, osteoporosis, loss of muscle mass, an increase in abdominal fat, development of breast tissue (gynecomastia) and infertility. Symptoms of low testosterone in women may include low libido (sex drive), sexual dysfunction, fatigue, loss of muscle mass, an increase in body fat and bone loss. Pituitary Symptoms There are many causes of low testosterone. These can be differentiated with hormone testing. Pituitary … Read more »

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Reading Time: 2 minutesRepros Therapeutics Inc. ( RPRX ) announced positive top-line data on its secondary hypogonadism candidate, Androxal, from a pivotal phase III study. Repros had initiated two identical, 17-week, double-blind ZA-304 and ZA-305 studies to compare the safety and efficacy of Androxal with a testosterone replacement therapy (topical gel) and placebo in restoring and maintaining testicular function. ZA-305 Study Data The ZA-305 study was the first of the two identical pivotal studies. In the study, Androxal demonstrated superiority on several assessments including the two co-primary endpoints and several secondary endpoints. In patients receiving Androxal, percent change in sperm concentration from baseline … Read more »

Reading Time: < 1 minuteExperts are calling for a full evaluation of the risks and benefits of hormone therapy for older men with declining levels of testosterone. The statement by the Endocrine Society was prompted by recent studies, one from the Veterans Health Care System and the other from the National Institutes of Health, that have raised concerns about the risks of testosterone therapy for older men with a history of heart disease. Testosterone is already approved for the treatment of hypogonadism, or low hormone production, because it is linked to diseases of the testes, pituitary and hypothalamus. But it has not been approved … Read more »

Reading Time: 2 minutesRepros Therapeutics Inc. ( RPRX ) reported second quarter 2014 loss of 38 cents per share, in line with the year-ago loss but a penny wider than the Zacks Consensus Estimate of a loss of 37 cents. Repros Therapeutics - Earnings Surprise | FindTheBest The company's revenues for the second quarter of 2014 were $2,000 as compared to $1,000 in the year-ago period, reflecting higher interest income as a result of a higher cash balance. Quarter in Details Both general and administrative (G&A) expenses and research and development (R&D) expenses were up during the reported quarter. While G&A expenses increased … Read more »

Reading Time: 8 minutesOverview Male hypogonadism is a condition in which the body doesn't produce enough of the hormone that plays a key role in masculine growth and development during puberty (testosterone) or enough sperm or both. You can be born with male hypogonadism, or it can develop later in life, often from injury or infection. The effects — and what you can do about them — depend on the cause and at what point in your life male hypogonadism occurs. Some types of male hypogonadism can be treated with testosterone replacement therapy Symptoms Hypogonadism can begin during fetal development, before puberty or … Read more »