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Hypogonadism clinical trials

View clinical trials related to Hypogonadism.

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NCT ID: NCT01403116 Completed - Male Hypogonadism Clinical Trials

Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Start date: July 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.

NCT ID: NCT01386606 Completed - Clinical trials for Secondary Hypogonadism

The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

Start date: June 2011
Phase: Phase 2
Study type: Interventional

The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (<350 ng/dL)after 6 weeks of continuous dosing.

NCT ID: NCT01386567 Completed - Hypogonadism Clinical Trials

A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203

Start date: July 2011
Phase: Phase 2
Study type: Interventional

The 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.

NCT ID: NCT01378299 Completed - Hypogonadism Clinical Trials

CYP19A1 (Cytochrome P450 Family 19 Subfamily A Member 1) Gene and Pharmacogenetics of Response to Testosterone Therapy

Start date: October 1, 2011
Phase: Phase 1
Study type: Interventional

Testosterone (T) replacement prevents bone loss and relieves symptoms associated with androgen deficiency in male patients with hypogonadism, but at the expense of an increase in prostate-related adverse events and in the hematocrit values above the normal which may lead to bad circulatory outcomes. Most of the effects of T on the male skeleton are mediated by its conversion to estradiol (E2) by the enzyme aromatase. Genetic variations in the aromatase (CYP19A1) gene result in enzymes with variable activity and variable levels of E2 and T. This project is designed to determine if genetic variations in the CYP19A1 gene will result in differences in the skeletal response and incidence of side effects from T treatment in patients with low T. A large number of male Veterans are on T. Results from this project will help identify patients who would benefit from the therapy from those at risk for side effects, and would definitely have an impact in the future care of these patients and male patients in general once genetic profiling becomes part of the standard of care.

NCT ID: NCT01370369 Completed - Clinical trials for Testicular Hypogonadism

Efficacy, Pharmacokinetics and Safety of Testosterone

Start date: May 2011
Phase: Phase 2
Study type: Interventional

This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations < 297 ng/dL.

NCT ID: NCT01323140 Completed - Hypogonadism Clinical Trials

Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems

Start date: April 2011
Phase: Phase 2
Study type: Interventional

Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.

NCT ID: NCT01270841 Completed - Clinical trials for Secondary Hypogonadism

Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

Start date: January 2011
Phase: Phase 2
Study type: Interventional

The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

NCT ID: NCT01252745 Completed - Hypogonadism Clinical Trials

Efficacy of an Intranasal Testosterone Product

Start date: August 2010
Phase: Phase 2
Study type: Interventional

This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

NCT ID: NCT01228071 Completed - Male Hypogonadism Clinical Trials

Time to Eugonadal Range, Time to Steady State and Drying Time

Start date: November 2010
Phase: Phase 3
Study type: Interventional

This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.

NCT ID: NCT01206270 Completed - Clinical trials for Klinefelter Syndrome

Androgen for Leydig Cell Proliferation

ALCeP
Start date: June 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Patients with infertility often presents alterations at ultrasonographic examination of the testis. These alterations include a much higher incidence of small, multiple, non-palpable hypoechoic micro-nodules that can show internal vascularization. This finding often create alarm and anxiety, because it has to be placed in a differential diagnosis versus low-stage malignant germ cell tumors. Nevertheless, explorative surgery reveal that a consistent number of these lesion are benign, due to Leydig cell hyperplasia or Leydig cell tumours. The purpose of this study is to evaluate the effects of androgen therapy on the size and number of non-palpable hypoechoic micro-nodules in patients with elevated gonadotropin levels.