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Hypogonadism clinical trials

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NCT ID: NCT00624624 Completed - Morbid Obesity Clinical Trials

Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism

Start date: September 2009
Phase: N/A
Study type: Observational

The purpose of this study is to determine the natural course of the androgen profile after bariatric surgery in men with obesity related hypogonadotropic hypogonadism.

NCT ID: NCT00613782 Completed - Type 2 Diabetes Clinical Trials

Reandron in Diabetic Men Witn Low Testosterone Level

Start date: January 2009
Phase: Phase 2/Phase 3
Study type: Interventional

In men with type 2 diabetes, low testosterone levels have been associated with insulin resistance, truncal obesity and symptoms such as fatigue and erectile dysfunction. Low testosterone may impair cardiac function and increase cardiovascular risk and cause osteoporosis. The goal of this project is to assess prospectively whether, in men with type 2 diabetes mellitus and low testosterone levels, testosterone replacement improves insulin resistance, body composition, bone density, cardiac function symptoms associated with low testosterone level. The investigators will recruit 140 ambulatory men with type 2 diabetes and a low serum testosterone level (<10 nmol/L) from Austin Health Endocrine clinics, General Practise surgeries, and from the general public by direct consumer advertising via newspaper and other local media. Men will be randomised to either intramuscular testosterone undecanoate (Reandron 1000, Bayer Schering Pharma) or placebo. Men with contraindications to testosterone replacement or to intramuscular injections will be excluded from the study. All men will receive intramuscular testosterone or placebo injections at 0, 6, 18 and 30 weeks (a total of four injections). All 140 study subjects will have a clinical and laboratory assessment at baseline, 18 weeks and at study end (40 weeks). All 140 subjects will also have imaging studies at baseline and at study end (40 weeks). The study protocol is outlined in more detail below: Clinical and laboratory assessment (Baseline and repeated 18 weeks, 40 weeks) A full medical history and physical examination will be performed. Symptoms will be assessed by the following standardised questionnaires: 1) Androgen Deficiency in the Aging Male (ADAM); 2) Aging Male Symptom scale (AMS); 3) International Index of Erectile Dysfunction (IIED); 4) International Prostate Symptom Score (IPSS); 5) SF-36 (all five questionnaires are attached to Module 1). Laboratory studies will consist of blood tests to measure total testosterone, fasting glucose, C-peptide, HBA1c and other routine parameters. Imaging studies (Baseline and repeated at 40 weeks) 1. Body composition and bone mineral density by DEXA 2. Body composition by magnetic resonance imaging 3. Bony micro-architecture by high resolution quantitative computed tomography [HR-pQCT]), 4. Cardiac dimensions and function by transthoracic doppler echocardiography

NCT ID: NCT00613288 Completed - Hypogonadism Clinical Trials

Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism

Start date: September 2007
Phase: N/A
Study type: Interventional

Testosterone(T) has known effects on many organ systems, although many of its metabolic actions are unrevealed. T is an anabolic hormone stimulating protein synthesis but this effect has barely been investigated in controlled studies. It also has lipolytic actions influencing body composition, but little is known of its regional impact on fat tissue. T affects insulin sensitivity. There is an increased incidence of hypogonadism in type 2 diabetes, and among patients with hypogonadism there is an increased incidence of type 2 diabetes. The actions of testosterone on glucose metabolism are unknown. The purpose of this study is therefore to: Investigate the lipolytic effect of testosterone on muscle and fat tissue. To gain insight in the intracellular mechanisms of testosterone on lipolysis and investigate possible regional differences in lipolysis and changes in body composition. Finally to investigate the effect of short term experimental hypogonadism and acute testosterone substitution on cytokines, insulin sensitivity and protein metabolism. The trial is a randomised double blinded cross-over study of 4 x 2 days with an interval of 1 month in between. 12 healthy young men will receive GnRH treatment over a 3 month period and examined on 4 occasions with various degrees of T substitution and placebo . The examinations take place at the Research Lab within the Medical Department M. The investigations are deemed relevant to the understanding of the interrelationship between male hypogonadism and type 2 diabetes. The hypothesis is that T has beneficial effects on carbohydrate, fat and protein metabolism. The generated knowledge would therefore hopefully improve prophylaxis, screening and early treatment of both group of patients.

NCT ID: NCT00597051 Completed - Hypogonadism Clinical Trials

Study of 3 Doses of ARD-0403 in Testosterone Deficient Men

ARD-0403-001
Start date: October 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine which dose, if any, results in testosterone levels within the normal range for 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: NCT00522431 Completed - Hypogonadism Clinical Trials

A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

Start date: August 2007
Phase: Phase 3
Study type: Interventional

Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms. The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.

NCT ID: NCT00504712 Completed - Type 2 Diabetes Clinical Trials

Testosterone for Peripheral Vascular Disease

Start date: February 2006
Phase: Phase 4
Study type: Interventional

There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men.

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.

NCT ID: NCT00494169 Completed - Clinical trials for Hypogonadotropic Hypogonadism

Investigation of the Genetic Causes of Kallmann Syndrome and Reproductive Disorders

Start date: January 1999
Phase:
Study type: Observational

The aims of this study are: 1) to identify genes that play a role in human pubertal development and reproduction, 2) to characterize the phenotypic spectrum of patients with these gene defects, and 3) to discern the mode of inheritance for disorders caused by these gene defects. We are specifically interested in genes that cause Kallmann syndrome, idiopathic hypogonadotropic hypogonadism (IHH), precocious (early) puberty, and delayed puberty. Individuals do not have to travel to Boston to participate in this study.