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Hypogonadotropic Hypogonadism clinical trials

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NCT ID: NCT05752591 Completed - Hypogonadism Clinical Trials

Hypothalamic-pituitary Dysfunction in Diabetes

DIAPO
Start date: May 25, 2018
Phase:
Study type: Observational

Type 2 Diabetes mellitus (T2DM) is a chronic disease with a high prevalence and several comorbidities impacting on public health and society. Among the complications of T2DM it has been showed a high prevalence of hypogonadotropic hypogonadism. Even if hypogonadism is associated to a worse metabolic profile and cardiovascular risk, it is discussed whether and when to treat this potentially reversible form associated to diabetes. In fact, the pathogenic mechanism of this condition in diabetic patients is not fully understood, and its clinical correlates, including the prevalence of other possible associated hypothalamic-pituitary axes dysfunctioning, questioned. The aim of the present study is to assess with an observational, cross sectional study on a large series of type 2 diabetic patients, enrolled consecutively: all the suspected etiologies of this complication in one single evaluation (both acquired and genetic congenital predisposition), its clinical correlates and the real prevalence of the disease using the lastly validated criteria for late onset hypogonadotropic hypogonadism.

NCT ID: NCT04456296 Completed - Hypogonadism Clinical Trials

A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism

Start date: June 30, 2020
Phase: Phase 4
Study type: Interventional

Testosterone is the principal androgen produced by the male testes. Hypogonadism is the result of inadequate production of testosterone by the Leydig cells of the testes and is reflected by total serum concentrations of testosterone of < 300 nanograms (ng)/deciliters (dL), with discernible diurnal pattern. The etiology of hypogonadism may be primary or secondary. The treatment of males with primary, and in some cases, secondary hypogonadism includes administration of testosterone. Testim® and Fortesta® are topical gels that when applied daily help to increase the total testosterone levels in the blood through skin absorption. Aveed® is an injectable form of testosterone treatment and participants randomized to this treatment arm will receive 3 injections over the course of 16 weeks. This study is designed to evaluate the effect on blood pressure of approved testosterone products (Testim®, Fortesta®, and Aveed®) after 16 weeks of therapy using 24-hour ambulatory blood pressure to reveal shifts in blood pressure levels.

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: NCT02908074 Completed - Clinical trials for Hypogonadotropic Hypogonadism

A 6 Month Safety Extension Study of MBGS205

Start date: November 15, 2016
Phase: Phase 2
Study type: Interventional

Phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism (HH)

NCT ID: NCT02730169 Completed - Clinical trials for Hypogonadotropic Hypogonadism

Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

Start date: May 12, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism. All subjects will be treated for a maximum of 24 weeks. Some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (Protocol MBGS206). The study is planned to enroll 268 subjects.

NCT ID: NCT02369796 Completed - Clinical trials for Hypogonadotropic Hypogonadism

A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism

Start date: February 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of subcutaneous dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese males with hypogonadotropic hypogonadism (HH).

NCT ID: NCT02154477 Completed - Clinical trials for Hypogonadotropic Hypogonadism

Effect of Intranasal Insulin on LH Concentrations in Man

Start date: December 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Over 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.

NCT ID: NCT02110368 Completed - Clinical trials for Hypogonadotropic Hypogonadism

Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions

Start date: March 2014
Phase: Phase 3
Study type: Interventional

Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.

NCT ID: NCT02062307 Completed - Insulin Resistance Clinical Trials

Bone Mineral Markers in Hypogonadism

Start date: August 2012
Phase: N/A
Study type: Observational

The aim of this study is to investigate the markers of bone mineral metabolism in an unconfounded group of patients with hypogonadism and to search for a relationship between endothelial dysfunction and insulin resistance.

NCT ID: NCT01709331 Completed - Hypogonadism Clinical Trials

A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adult Men With Hypogonadotropic Hypogonadism (HH) (P07937)

Start date: February 11, 2013
Phase: Phase 3
Study type: Interventional

This study will assess if corifollitropin alfa (MK-8962), when administered in combination with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who remain azoospermic after treatment with hCG alone. Hypothesis: The lower limit of the 95% confidence interval for the geometric mean increase in testicular volume from Day 1 to Week 52 is greater than one.