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Hypogonadism, Male clinical trials

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NCT ID: NCT03973840 Completed - Hypogonadism, Male Clinical Trials

Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes

Start date: July 15, 2018
Phase: Phase 1
Study type: Interventional

To describe the rate of post-collection TU to testosterone conversion, as manifested by increases in testosterone concentration, in Plain tubes held at room temperature and sodium fluoride (NaF)-ethylenediaminetetraacetic acid (EDTA) tubes held at room temperature or on ice prior to centrifugation

NCT ID: NCT03933618 Completed - Hypogonadism, Male Clinical Trials

Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function

CAP
Start date: April 2, 2015
Phase: Phase 2
Study type: Interventional

This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day and placebo in randomized schedule of 8 week intervals.

NCT ID: NCT03868059 Completed - Hypogonadism, Male Clinical Trials

Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men

Start date: April 30, 2018
Phase: Phase 3
Study type: Interventional

This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.

NCT ID: NCT03851627 Recruiting - Fatty Liver Clinical Trials

Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism

Test2Func
Start date: January 25, 2022
Phase: Phase 4
Study type: Interventional

The epidemics of obesity, MeTSy, T2DM and CVD are increasing worldwide. Non-alcoholic fatty liver disease (NAFLD) is becoming recognized as a condition possibly involved in the pathogenesis of these diseases. The prevailing hypothesis for NAFLD pathogenesis is the 'two-hit' model, with insulin resistance and hyperinsulinemia playing essential roles, which have a plethora of effects on hepatic lipid metabolism and can lead to accumulation of triglycerides in hepatocytes. Accepted treatment for NAFLD is lifestyle modifications. Sex hormones might be relevant in T2DM development and treatment. Low testosterone (T) has deteriorating effects on glucose levels, and aggravates in obesity as aromatization of T is enhanced. T deficiency is related to increases of visceral fat accumulation and associated with development of NAFLD. T replacement might be a successful way in hypogonadism to treat obesity and counteract progression of MEtSy,T2DM or CVD driven by visceral fat accumulation or NAFLD. Primary Objective To investigate the effects on hepatic lipid content reduction of a therapy with Testosterone undecanoate 1000mg compared to placebo given for 52 weeks in patients with type 2 diabetes mellitus and hypogonadism.

NCT ID: NCT03792321 Completed - Obesity Clinical Trials

Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)

SETH2
Start date: January 10, 2014
Phase: Phase 4
Study type: Interventional

Aim of the study was to investigate the effects of testosterone replacement therapy on components of metabolic syndrome, vascular function and morphology, grade of non-alcoholic fatty liver disease (NAFLD), bone mineral density (BMD) and health-related quality of life.

NCT ID: NCT03747003 Completed - Clinical trials for Erectile Dysfunction

Gonadal Function in Young to Middle Aged HIV-infected Men

Start date: May 15, 2013
Phase:
Study type: Observational

HIV infection is associated to premature decline of serum testosterone. However, prevalence and biochemical characterization of hypogonadism in HIV-infected men are still to be well defined. HIV-infection is strongly associated to erectile dysfunction in men, but preliminary data suggest that it is poorly associated with serum testosterone in this context.

NCT ID: NCT03541395 Completed - Hypogonadism, Male Clinical Trials

Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males

Start date: March 2015
Phase: N/A
Study type: Interventional

The study is designed to identify and validate new protein biomarkers in blood related to testosterone activity. Thirty healthy young males underwent pharmaceutical castration to lower testosterone levels. After three weeks the subjects received an intramuscular injection of testosterone undecanoate. Blood samples from just before pharmaceutical castration, three weeks after castration, and one week after injection of testosterone undecanoate were collected representing normal testosterone levels, low testosterone levels, and testosterone at eugonadal levels.

NCT ID: NCT03335254 Terminated - Hypogonadism Clinical Trials

A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males

Start date: November 6, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This will be a phase 1/2a, open-label, single-center study with 3 periods. The aims of the study are to: 1. evaluate the dose-response curve following ascending single doses of TSX-011; 2. confirm optimum dosing conditions; 3. evaluate the efficacy of single or multiple daily adaptive dosing; and 4. evaluate the safety and tolerability of TSX-011.

NCT ID: NCT03282682 Completed - Physical Activity Clinical Trials

Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

This study examines the effect of 12-week strength training program with and without testosterone replacement therapy (TRT) on body composition, physical function, selected biochemical markers of metabolic health, molecular parameters of training adaptation and the quality of life patients with ADAM. The investigators believe, that strength training program performed 2 times per week for 12 weeks can improve body composition (decrease fat mass and gain lean mass), muscle strength, muscle power and general quality of life in all training groups. In addition, combination TRT and strength training could help decrease fat mass, improve BMI, cardio-respiratory fitness and thus provide optimal therapy combination for hypogonadal ageing males.

NCT ID: NCT03254641 Completed - Hypogonadism, Male Clinical Trials

Calciotropic Effects After hCG Stimulation Test

Start date: April 1, 2017
Phase:
Study type: Observational

We have in a pilot study found that serum calcium levels change in response to hCG stimulation test. We observed that serum calcium level measured at baseline and 72 hours after hCG stimulation were different in men with gonadal insufficiency referred for this stimulation test. Now we want to investigate a large cohort of men referred for hCG stimulation test due to suspected impaired gonadal function.