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Hypogonadism clinical trials

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NCT ID: NCT04833426 Recruiting - Prostatic Neoplasms Clinical Trials

Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy

ENFORCE
Start date: December 12, 2022
Phase: Phase 3
Study type: Interventional

Sexual dysfunction is a common side effect of radical prostatectomy (RP) and has a significant negative impact on quality of life. With age the testosterone level in men declines; around 30% of men over 70 years of age meet the criteria of testosterone deficiency (TD). The negative impact of both TD and RP on sexual performance are likely to add up. The aim of this study is to assess the efficacy and safety of testosterone replacement therapy (TRT) on functional and oncological outcomes in testosterone deficient men following RP for prostate cancer (PCa).

NCT ID: NCT04798469 Recruiting - Pain Clinical Trials

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

PATH
Start date: January 10, 2022
Phase: Phase 2
Study type: Interventional

The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic back pain treated with opioids who have opioid-induced hypogonadism (low testosterone).

NCT ID: NCT04760574 Recruiting - Clinical trials for Hypogonadism; Ovarian

Association Between Human Immunodeficiency Virus (HIV) Infection and Male Hypogonadism

Start date: February 2, 2021
Phase:
Study type: Observational [Patient Registry]

Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population

NCT ID: NCT04731376 Recruiting - Hypogonadism Clinical Trials

Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone

Start date: January 25, 2021
Phase: Phase 1
Study type: Interventional

This phase I trial investigates the safety of testosterone replacement therapy around the time of major urologic surgery (perioperative) in order to improve quality of life and post-operative outcomes such as decreased length of hospital stay, complications, and mortality in patients with low testosterone levels. Studies have demonstrated that patients undergoing testosterone replacement therapy have increased lean body mass, decreased fat mass and have improved physical function. Testosterone replacement therapy can also stimulate bone formation and may decrease the risk of fracture. Information from this trial may be used to support the incorporation of testosterone level testing and testosterone replacement into the perioperative treatment decision-making process.

NCT ID: NCT04648969 Recruiting - Clinical trials for Hypogonadotropic Hypogonadism

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Start date: January 20, 2021
Phase: Phase 2
Study type: Interventional

The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.

NCT ID: NCT04460872 Recruiting - Clinical trials for Spinal Cord Injuries

Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury

Start date: January 31, 2021
Phase: Phase 2
Study type: Interventional

This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.

NCT ID: NCT04301765 Recruiting - Cancer Clinical Trials

Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency

TEMEC
Start date: January 12, 2021
Phase: Phase 2
Study type: Interventional

This is a large randomized, double-blind, placebo-controlled trial to determine the efficacy of testosterone replacement on cancer-related fatigue in older men with solid or hematologic (blood) cancer who report fatigue and have low testosterone levels.

NCT ID: NCT04189133 Recruiting - Clinical trials for Acquired Hypogonadotropic Hypogonadism

Rec-LH PD and Safety Profile in Hypogonadotropic Hypogonadism Men

RHYTHM
Start date: January 19, 2022
Phase: Phase 2
Study type: Interventional

Objectives: The overall clinical question is whether LH supplementation to men in indication for FSH according to the AIFA note 74, or with HH, will improve spermatogenesis and pregnancy rate (spontaneous or after ART) over FSH alone or FSH+hCG. However, since LH has never been used in men so far, the first, specific object of this study is the assessment of pharmacodynamics and safety profile of LH in HH men. To this end, this study will evaluate the pharmacodynamics and safety profile of recombinant LH (Luveris) and compare the response to Luveris and urinary hCG (Gonasi HP) in HH men. The pharmacodynamics will be assessed primarily for testosterone levels in response to increasing doses of LH and the comparison of the response to a fix dose of hCG, and later for more extend steroid profile. Methods: Multicentre longitudinal, interventional, randomized, open-label, phase II, clinical trial, assessing pharmacodynamics of LH in acquired HH men. The statistical hypothesis is non-inferiority of the highest LH dose employed compared to a fix hCG dose. Primary endpoint: serum testosterone levels evaluated by liquid-chromatography, tandem mass spectrometry (LC-MS/MS). Secondary endpoints: Safety and tolerability as determined by AE reporting, vital signs, and ECG, stereognosis (inhibin B, free testosterone, sex hormone binding globulin (SHBG), estradiol, whole steroid profile provided by LC-MS/MS) and testicular volume. Patients: 32 men with acquired HH, including HH after neurosurgery for tumours or HH due to pituitary adenoma-related mass effect. Patients will be randomized (1:1) according to a permuted- blocks randomization list, to the study group, treated with Luveris (increasing doses at two weekly intervals), or to the control group treated with Gonasi HP (2000 IU twice/week). In the study group, increasing LH dosages will be administered to obtain a testosterone dose-response curve, starting with the minimum expected efficient dose (75 IU/d, sc) for two weeks followed by 150, 225 and 300 IU at two-weekly interval, respectively. The control group will be treated by the standard approach, i.e. hCG 2000 IU IM twice-weekly for 8 weeks. Patients will be further followed up for 4 weeks after treatment withdrawal. During the study, the patients will be evaluated two times per week during the treatment phase and every two weeks in the follow-up phase.

NCT ID: NCT04049331 Recruiting - Hypogonadism, Male Clinical Trials

Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

Start date: March 22, 2021
Phase: Phase 2
Study type: Interventional

The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. Main hypothesis is that Testosterone administration in young male cancer survivors who are in remission for at least 1 year, report cancer-related fatigue and have symptomatic testosterone deficiency will be associated with greater improvements in fatigue scores compared with placebo.

NCT ID: NCT03887936 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism

Start date: October 1, 2019
Phase: Phase 4
Study type: Interventional

Low testosterone and diabetes mellitus are each associated with increased risk for fractures. Men with diabetes mellitus are commonly found to have low testosterone as well. Testosterone has been shown to improve the bone health of patients with low testosterone but has not been tested in patients who also have diabetes mellitus in addition to low testosterone. To date, there is no treatment that is specifically recommended for bone disease among patients with diabetes. This study will evaluate the effect of testosterone on the bone health of male Veterans who have both diabetes and low testosterone, both of which are highly prevalent in this subset of the population.