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Hypogonadism clinical trials

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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: NCT01148433 Completed - Hypogonadism Clinical Trials

Quality of Life With TESTIM®

LIFE
Start date: May 2010
Phase: N/A
Study type: Observational

The present non-interventional study is to document the testosterone levels in patients with clinical symptoms such as loss of sexual desire indicating hypogonadism (testosterone deficiency syndrome). During testosterone replacement therapy with TESTIM®, the changes in the quality of life - especially with respect to motivation, activity and fatigue - of hypogonadal patients will be documented and correlated with the testosterone levels during the course of therapy.

NCT ID: NCT01143818 Completed - Hypogonadism Clinical Trials

ESPRIT Study in Hypogonadal Men

Start date: December 2007
Phase: Phase 4
Study type: Observational

Observational study with AndroGel®, Testosterone 1% gel therapy (ESPRIT) in hypogonadal men in the community over 6 months.

NCT ID: NCT01133548 Completed - Hypogonadism Clinical Trials

Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males

Start date: May 2010
Phase: Phase 1
Study type: Interventional

To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

NCT ID: NCT01127659 Completed - Hypogonadism Clinical Trials

Testosterone Replacement in Men With Diabetes and Obesity

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

The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes and with obesity. The study will also evaluate the effect of testosterone therapy. This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic or obese-non diabetic men with low testosterone levels and comparing them to diabetic or obese-non diabetic men with low testosterone who are not treated with testosterone.

NCT ID: NCT01123278 Completed - Obesity Clinical Trials

Testosterone Replacement in Metabolic Syndrome and Inflammation

TERMSINFAT
Start date: January 2004
Phase: Phase 4
Study type: Interventional

Hypogonadism (HG) frequently complicates the Metabolic Syndrome (MetS), whether testosterone replacement (TRT) is beneficial has not been clearly ascertained. This study was designed to address the effects of TRT on insulin resistance, body composition and pro-inflammatory status in naïve patients with MetS and HG.

NCT ID: NCT01107067 Completed - Hypogonadism Clinical Trials

Testosterone Replacement Therapy Decreases Plasma Paraoxonase 1 Enzyme Activity In Male Patients With Hypogonadism

Start date: June 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is investigating the effect of testosterone treatment on paraoxonase level in male patients with hypogonadotrophic hypogonadism

NCT ID: NCT01104246 Completed - Hypogonadism Clinical Trials

Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men

Start date: April 2010
Phase: Phase 1
Study type: Interventional

The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.

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.