An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Secondary HypogonadismTo determine the safety profile of Androxal in men with secondary hypogonadism.
Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary...
Secondary HypogonadismThe purpose of ZA-302 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.
A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone...
HypogonadismThe main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have...
HypogonadismLow TestosteroneThe purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.
Testosterone Therapy in Hypogonadal Men Treated With Opioids
HypogonadismThe purpose of this study is to evaluate the efficacy of testosterone replacement therapy in men with low testosterone due to opioid treatment on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life. Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40 patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20 patients per arm A double blinded randomized placebo controlled trial
Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes MellitusHypogonadismA randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM. Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance. Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.
Endothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect...
Hypogonadotrophic HypogonadismThe study searched for answers to two questions Is there endothelial dysfunction, inflammation and insulin resistance in patients with congenital hypogonadotropic hypogonadism? What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?
Pharmacokinetic Study of Testosterone Enanthate
HypogonadismRelative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.
A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
Adult Male HypogonadismThis is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism...
Secondary HypogonadismApproximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.