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Hypogonadism clinical trials

View clinical trials related to Hypogonadism.

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NCT ID: NCT03242590 Completed - Hypogonadism, Male Clinical Trials

Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).

DV
Start date: December 2016
Phase: Phase 3
Study type: Interventional

Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.

NCT ID: NCT03242408 Completed - Hypogonadism, Male Clinical Trials

Dosing Flexibility Study of Oral Testosterone Undecanoate (TU, LPCN 1021)

DF
Start date: January 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.

NCT ID: NCT03203681 Completed - Hypogonadism, Male Clinical Trials

Natesto Effects on Testosterone, Luteinizing Hormone, Follicle Stimulating Hormone and Semen Parameters

Start date: October 27, 2017
Phase: Phase 4
Study type: Interventional

Low testosterone affects more than 10% of men worldwide, with high incidence in the elderly.This will be a prospective case study. The investigators will identify men with hypogonadism in our clinic interested in Natesto for testosterone replacement therapy (TRT). Natesto is a relatively new form of testosterone replacement therapy that is delivered intranasal to men diagnosed with low testosterone. Current advantages to Natesto include ease of delivery and decreased risk of transference. Recently Natesto 4.5% (125 uL/nostril, 11.0mg testosterone/dose), three times a day (TID) dosing was shown to also increase serum testosterone while maintaining normal, though decreased, serum levels of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone(FSH). 40 participants will be enrolled and receive treatment with Natesto.The study will identify men with confirmed hypogonadism (testosterone (T) <350 on 2 consecutive Testosterone samples collected greater than 1.5 hours apart between 6am and 10am with demonstrated symptoms of hypogonadism). Participants with a history of prostate cancer, testis cancer, azoospermia, or genetic cause of hypogonadism will be excluded.

NCT ID: NCT03198728 Completed - Hypogonadism, Male Clinical Trials

Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men

Start date: July 5, 2017
Phase: Phase 3
Study type: Interventional

This will be a randomized, multicenter, open-label, active-controlled, efficacy, and safety study in adult hypogonadal men. The study duration is 12 months (365 days), including a 90-day, open-label efficacy period and a 9-month (275-day) safety evaluation period.

NCT ID: NCT03126656 Completed - Clinical trials for Chronic Heart Failure

Effects of Testosterone on Myocardial Repolarization

Start date: September 2016
Phase: Phase 4
Study type: Interventional

The main of the study is to evaluate the effect of testosterone on ventricular repolarization in patients with mild heart failure, at risk for sudden cardiac death. The electrocardiographic markers studied are QT variability index, the short term variability index.

NCT ID: NCT03091348 Completed - Hypogonadism, Male Clinical Trials

Subcutaneous vs. Intramuscular Testosterone

Start date: August 29, 2017
Phase: Phase 4
Study type: Interventional

In this randomized, cross‐over study 20 subjects who are undergoing testosterone (T) therapy for the treatment of T deficiency will receive both subcutaneous testosterone therapy and intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM injection and one group will receive an IM injection followed by a SQ injection. The primary objective of this study is to measure testosterone concentration in men after these two treatment routes and determine if there are any significant differences due to modes of administration. Endpoints will include total serum testosterone and calculated free testosterone. A questionnaire will also be administered to assess overall patient experience with each route of administration.

NCT ID: NCT03063125 Completed - Bladder Cancer Clinical Trials

Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer

Start date: March 31, 2017
Phase:
Study type: Observational

The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.

NCT ID: NCT03057899 Completed - Hypogonadism Clinical Trials

Efficacy of Fenugreek Seed and Lespedeza Cuneata in TDS

Start date: June 2015
Phase: Phase 4
Study type: Interventional

Objective: The aim of this study was to investigate the efficacy and safety of a mixed extract of fenugreek seed and Lespedeza cuneata (TFG) for the treatment of testosterone deficiency syndrome (TDS). Design: Patients were instructed to take a placebo capsule or 200 mg TFG capsule twice per day for 8 weeks. Outcome measures: The primary efficacy variable was the change from baseline in the Aging Males' Symptoms scale (AMS), as well as levels of serum total testosterone and free testosterone. Secondary efficacy measurements included changes from baseline in the number of 'yes' answers on the Androgen Deficiency in the Aging Male questionnaire (ADAM), levels of serum total cholesterol, HDL-C, LDL-C, triglyceride, perceived stress scale (PSS-10), all domain scores of the International Index of Erectile Function (IIEF), as well as changes in body composition.

NCT ID: NCT03019575 Completed - Clinical trials for Hypogonadotropic Hypogonadism

Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043)

Start date: February 2, 2017
Phase: Phase 3
Study type: Interventional

The purpose of the study is to investigate whether corifollitropin alfa (MK-8962), administered alone for 12 weeks and then in combination with human chorionic gonadotropin (hCG) for 52 weeks, increases the testicular volume in adolescent males aged 14 to <18. In addition, the study will evaluate participants for safety, tolerability and for the development of corifollitropin alfa antibodies. No formal hypothesis will be tested for this estimation study

NCT ID: NCT02966652 Completed - Male Hypogonadism Clinical Trials

Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism

Start date: November 3, 2016
Phase: Phase 1
Study type: Interventional

DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed to evaluate the pharmacokinetic (PK) characteristics of DITEST, and to assess the safety and tolerability of DITEST in the target population.