View clinical trials related to Hypogonadism.
Filter by:To determine the safety profile of Androxal in men with secondary hypogonadism.
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 TSX-002, which is testosterone provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within the normal range in hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of TSX-002, which will be taken orally twice per day for 15 days. In addition, the study is intended to determine a dosing regimen(s) that achieves testosterone levels within the normal range. Related Outcome Measures will be reported for Parts 1, 2, and 4. A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal on the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be reported for Part 3.
This study will assess if corifollitropin alfa (MK-8962), when administered in combination with human chorionic gonadotropin (hCG), will increase testicular volume in men with HH who remain azoospermic after treatment with hCG alone. Hypothesis: The lower limit of the 95% confidence interval for the geometric mean increase in testicular volume from Day 1 to Week 52 is greater than one.
This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.
This study will elucidate how the parental origin of the X-chromosome influences health status as well as metabolic fate in Klinefelter patients. Epigenetics and transcriptome-research will be directly linked to the metabolic and inflammatory pattern of actual patients to improve care for them. The Klinefelter Syndrome is one of the most common genetic disorders in men. The patients have one supernumerary X-chromosome, which is partly active and disturbs a normal male development. Testosterone deficiency in form of primary hypogonadism is a common feature in these men. Such a condition promotes clinically relevant metabolic patterns related to a pro-inflammatory status and diabetes mellitus type 2 (insulin resis-tance), cardiovascular disease as well as infertility. However, the variety of pathologies is pro-nounced between patients and low testosterone concentrations cannot fully explain the wide scope of pathologies in these men. Some patients become clinically obvious during puberty and adoles-cence, some in their thirties or later and all exhibit a huge variation in phenotype. Switching on and off of specific genes on the X-chromosome is differential, depending on the origin either from the maternal or paternal side. Hence, an influence on the clinical picture is hypothesised. Thus, key targets are clarification of the parental origin of the supernumerary X chromosome and elucidation of methylation and expression profile of pivotal X-chromosomal genes. These will be related to clinically relevant metabolic and inflammatory patterns as well as fertility to identify individual risks as well as treatment strategies for Klinefelter patients.
The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.
This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.
The aim of the study is to compare the efficacy and safety of r-hFSH+r-hLH in a 2:1 ratio with human Menopausal Gonadotropin Highly Purified (hMG-HP), in WHO type I anovulation, HH women. This open-label monocentric, randomized comparative trial, to receive the two different standard clinical practice treatments: - 1 vial of Pergoveris: (vial/powder 150 International unit (IU) r-hFSH+ 75IU r-hLH) - 2 vials of Menopur: (vials/powder hMG 75IU). Follicular development were monitored until the protocol hCG requirement is met and a single injection of hCG was administered. Main Outcome Measures were follicular development i.e. follicle ≥ 17 millimeters (mm), pre-ovulatory E2 ≥ 400 picomole/Liter (pmol/L) and mid-luteal phase Progesterone (P4) ≥ 25 nanomole/Liter (nmol/L).
To determine the effects of 12 months of treatment with Androxal on bone mineral density in men with secondary hypogonadism.
The aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH).