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Hypogonadism clinical trials

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NCT ID: NCT00695110 Completed - Hypogonadism Clinical Trials

Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men

Start date: June 2008
Phase: Phase 2
Study type: Interventional

The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.

NCT ID: NCT00663793 Completed - Contraception Clinical Trials

ORAL T-6: Oral Androgens in Man-6

ORAL-T-6
Start date: October 2008
Phase: Phase 1
Study type: Interventional

We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.

NCT ID: NCT00647868 Completed - Hypogonadism Clinical Trials

NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers

Start date: May 2008
Phase: Phase 1
Study type: Interventional

In this study the serum concentration of testosterone and its main metabolite DHT will be measured in hypogonadal men using intranasal testosterone (Nasobol). Different treatment regimens (once and twice daily) and administration times will be tested. The serum levels obtained will be compared with those of healthy men. It is expected that intranasal administration of Nasobol will restore testosterone and DHT levels to nearly normal.

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: 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: 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.