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Hypogonadism clinical trials

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NCT ID: NCT01200862 Terminated - Clinical trials for Obese Hypogonadotropic Hypogonadism

Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men

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

This study is designed as a 2-part study, with Part 1 being open-label to best determine the appropriate dose levels to use in Part 2, which has a randomized, double-blind, placebo controlled design. The study aims to assess the safety and tolerability of BGS649, and determine whether or not BGS649 is able to normalize testosterone levels and improve insulin sensitivity in obese, hypogonadotropic hypogonadal (OHH) men

NCT ID: NCT01165619 Terminated - Clinical trials for Idiopathic Hypogonadotropic Hypogonadism

Detailed Clinical, Biochemical and Genetic Characterization in Gonadotropin-releasing Hormone (GnRH) Deficiency Disorders

Start date: June 2010
Phase: N/A
Study type: Observational

In this study, we will measure levels of reproductive hormones and metabolic markers in subjects with isolated GnRH deficiency disorders and compare them to healthy control populations. Our goals are (1) to chart the range of hormonal and metabolic biomarkers in healthy subjects and those with reproductive disorders and (2) to correlate reproductive and metabolic phenotypes with genetic changes within patients with reproductive disorders and healthy controls.

NCT ID: NCT01155518 Terminated - Type 2 Diabetes Clinical Trials

Hypogonadism in Young Men With Type 2 Diabetes

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

Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. In this grant, the investigators propose to study the effects of having low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat and muscle mass at specific areas of the body 3) expression of mediators of inflammation in the blood 4) semen quality. This study will compare diabetic men (with or without hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug that increases testosterone and sperm production) or testosterone in men with diabetes and hypogonadism. The investigators hope that this project will help us understand the state of hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us insights into treatment of this condition. With the rising prevalence of type 2 diabetes in the young, this project may have implications for public health.

NCT ID: NCT01092858 Terminated - Hypogonadism Clinical Trials

NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

Start date: September 2010
Phase: Phase 4
Study type: Interventional

The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks, to monitor the increase as well as the "steady state" of the parameters assessed.

NCT ID: NCT01084369 Terminated - Type 2 Diabetes Clinical Trials

Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism

Start date: October 11, 2013
Phase: Phase 4
Study type: Interventional

Diabetes mellitus is associated with long-term complications affecting mainly the eyes, nerves and kidneys. One of the main underlying causes for this is damage to the lining of the small blood vessels supplying these organs with dysfunction of the endothelium (lining of the small blood vessels). Testosterone has been shown to have an effect macro (large) blood vessels with limited data available on the micro (small) blood vessels. Testosterone is recognised to have important effects on metabolism and vascular behaviour beyond the accepted effects on secondary sexual characteristics. Physiological testosterone therapy is associated with some beneficial effects on the cardiovascular system and has been used with some success to treat patients with stable angina and chronic heart failure. The investigators therefore propose to study the effects of testosterone replacement therapy in patients with hypogonadism (low testosterone levels) on the endothelium in males with type 2 diabetes. 40 diabetic patients with type 2 diabetes and low testosterone levels and erectile dysfunction (impotence) will be recruited into the study. All patients will receive testosterone replacement therapy and 10 patients will also receive Vardenafil (a drug used to treat impotence). The investigators hope to demonstrate an improvement in endothelial dysfunction by assessing biochemical markers such as nitric oxide (a chemical that causes relaxation for the blood vessels) and C-reactive protein (a chemical that can increase in patients with diabetes) as well as the effect on weight, blood pressure, diabetes control and cholesterol.

NCT ID: NCT00848497 Terminated - Clinical trials for Erectile Dysfunction

Testosterone for Penile Rehabilitation After Radical Prostatectomy

Start date: November 2007
Phase: Phase 0
Study type: Interventional

The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function. Subjects will be randomized (like flipping a coin) to one of two groups. One group will receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and the other will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night. Subjects will begin drug treatment 3 months after the initial screening visit and will take study drug for 3 months only. Participation will end at the end of the 6-month visit.

NCT ID: NCT00743327 Terminated - Diabetes Clinical Trials

Androgen Deprivation Therapy Study

ADT
Start date: October 2008
Phase: N/A
Study type: Observational

The purpose of this study is to examine the link between low testosterone and insulin resistance/diabetes in men undergoing androgen deprivation therapy for prostate cancer. The study will also evaluate other cardiovascular risk factors in these men.

NCT ID: NCT00562731 Terminated - Hypogonadism Clinical Trials

Open-Label Study of ARD-0403 in Testosterone Deficient Men

ARD-0403-010
Start date: October 2007
Phase: Phase 3
Study type: Interventional

Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient well-being. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.

NCT ID: NCT00529230 Terminated - Pain Clinical Trials

Prevalence of Secondary Hypogonadism in Male Patients on Chronic Opioid Therapy for Cancer-Related Pain Syndromes

Start date: December 11, 2001
Phase:
Study type: Observational

Primary Objective: 1. To determine the prevalence of secondary hypogonadism in male patients on chronic opioid therapy for cancer-related pain syndromes. Secondary Objective: 1. To determine the degree of sexual dysfunction, fatigue, and depression prevalent in male patients on chronic opioid therapy for cancer-related pain syndromes.

NCT ID: NCT00504218 Terminated - Hypogonadism Clinical Trials

Detection and Treatment of Endocrine Abnormalities in Childhood Cancer Survivors and Hematopoietic Stem Cell Transplant Recipients

Start date: July 17, 2007
Phase:
Study type: Observational

This study will determine the prevalence of endocrine-related side effects in children who have been treated for cancer and establish a database and registry organized according to cancer diagnosis, treatments and endocrine side effects. In children, the endocrine system, which includes glands and hormones that help to control metabolism, growth, development and reproduction, is particularly vulnerable to long-term side effects associated with cancer and its treatments. The study will also serve to help train medical fellows, residents and students in identifying and managing endocrine abnormalities in children who have been diagnosed with and treated for cancer. Children between 2 and 24 years of age who have been treated for a childhood cancer and have been disease-free for at least 1 year may be eligible for this study. All participants undergo the following procedures: - Review of cancer treatment record - Review of medical and family history - Blood draw for DNA studies - Physical examination and body measurements (height, weight, waist, body proportions) - Completion of child health questionnaires - Individualized screening and counseling program - Review of the following endocrine systems: growth, pituitary and hypothalamic function, thyroid function, ovary and testicular function, bone health, risk of obesity and diabetes The following additional studies may be done, as clinically indicated: - Magnetic resonance imaging (MRI) of the brain - Thyroid, testicular or ovarian ultrasound - DEXA scan to measure bone density - Wrist x-ray to measure bone age - Blood tests - Urine pregnancy test for girls who are old enough to have menstrual periods - Stimulation testing (tests that involve giving medicine by mouth or in the vein and then measuring blood levels of substances afterwards, such as oral glucose tolerance test, arginine-clonidine growth hormone stimulation test, ACTH stimulation test, and gonadotropin-releasing hormone stimulation test) Children with endocrine abnormalities are offered standard treatments.