Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal...
HypogonadismWatson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.
Safety and Efficacy Trial of Testosterone Undecanoate
Male HypogonadismThe purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism...
HypogonadismEvaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector
Effect of Intranasal Insulin on LH Concentrations in Man
Hypogonadotropic HypogonadismOver the last few years, studies have shown that men with type 2 diabetes sometimes develop a condition called hypogonadotrophic hypogonadism (HH). People with this condition produce little or no sex hormones. Obesity and metabolic syndrome are also associated with HH. Research suggests that insulin in the brain may benefit the glands that release these hormones. During this study, subjects will spray a small amount of insulin into their nose.This will increase insulin concentrations in the brain. The purpose of this study is to find out the effect of one dose of intranasal insulin on release of LH (a sex hormone) in obese diabetic men with HH.
Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication...
HypogonadismOpioid-Related Disorders1 moreThe purpose of this randomized controlled clinical trial is to evaluate the effects of clomiphene citrate compared to placebo (substance without active medication) in men who are taking pain medication (opioids) for chronic pain conditions and who have low blood testosterone levels. The condition of men having low testosterone with long-term pain medication (opioid) usage is called opioid-induced androgen deficiency (OPIAD). Low testosterone can be caused by pain medication effects on part of the brain (hypothalamic-pituitary axis) which ultimately result in decreased testosterone production by the testes. Typical symptoms of low testosterone (hypogonadism) may include decreased muscle mass, increased fat, osteoporosis, anemia, erectile dysfunction, delayed ejaculation. In addition, men with low testosterone may experience decreased attention, and decreased libido, fatigue, and depressed mood. Few studies have looked at hormonal changes caused by long-term opioid usage in men. Clomiphene citrate, a selective estrogen receptor modulator (SERM) oral medication which inhibits estrogen effects (feedback) on the brain, has been identified by prior studies to raise testosterone in men with low testosterone (due to reasons other than chronic pain medication). Clomiphene citrate is also known to lead to increased sperm production in men with low testosterone unlike testosterone topical or injection medications. Although clomiphene citrate has been studied in hypogonadal men with beneficial outcomes and minimal side effects, no group has previously studied clomiphene citrate as treatment in patients with OPIAD.
The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response...
HypogonadismThis study will evaluate if testosterone solution can raise testosterone hormone levels into the normal range after treatment for up to 9 Weeks, in those participants with a documented history of subtherapeutic levels [total testosterone <300 nanograms per deciliter (ng/dL)] when previously treated with a topical testosterone gel.
Clomid in Men With Low Testosterone With and Without Prior Treatment
HypogonadismMaleThis study aims to explore whether men with low testosterone levels, due to altered brain regulation of male hormone function, who have been previously treated with testosterone, respond as well as men who have not been so treated to clomiphene citrate, an agent commonly used for female infertility that has been shown to improve male hormone secretion in some cases.
Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS)
Nonalcoholic SteatohepatitisHypogonadismThe main research questions are: In hypogonadal men with non-alcoholic steatohepatitis (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months improve severity of steatosis on liver biopsy (Primary Question)? improve severity of associated steatohepatitis on liver biopsy? reduce liver fat content as assessed by proton Magnetic Resonance Spectroscopy (1H-MRS)? The work proposed here is an open pilot study of 10 patients, the main aim of which is to assess the effect size of TRT in regard to these end points (regarding which there are no published data), thereby allowing power calculations for a more definitive phase II trial. Other aims would be assessing recruitment and consent rates, which would also inform the design of the larger study.
Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism...
Secondary HypogonadismThe purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes...
Type 2 Diabetes MellitusSecondary HypogonadismThe purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism