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Hypogonadism clinical trials

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NCT ID: NCT02369796 Completed - Clinical trials for Hypogonadotropic Hypogonadism

A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism

Start date: February 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of subcutaneous dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese males with hypogonadotropic hypogonadism (HH).

NCT ID: NCT02367105 Completed - Clinical trials for Obesity and Hypogonadism

Lifestyle Intervention and Testosterone Replacement in Obese Seniors

LITROS
Start date: February 1, 2015
Phase: Phase 3
Study type: Interventional

The prevalence of obesity in Veterans is greater than in the general population, and even more so among users of the VA Health Care System. In addition, the population of obese older Veterans is rapidly increasing as more baby boomers become senior citizens. In older Veterans, obesity exacerbates the age- related decline in physical function and causes frailty which predisposes to admission to a VA chronic care facility. However, the optimal clinical approach to obesity in older adults is controversial because of the concern that weight loss therapy could be harmful by aggravating the age-related loss of muscle mass and bone mass. In fact, the MOVE (Managing Overweight/Obese Veterans) program does not have any guidelines for eligible Veterans if they are 70 or older. It is possible that the addition of testosterone replacement to lifestyle therapy will preserve muscle mass and bone mass and reverse frailty in obese older Veterans and thus prevent their loss of independence and decrease demand for VA health care services.

NCT ID: NCT02366975 Completed - Clinical trials for Lower Urinary Tract Symptoms

TRT on BPH Hypoganadal MetS Patients. Florence-PROTEST

PROTEST
Start date: November 2012
Phase: Phase 4
Study type: Interventional

There are many evidences in the literature showing that the metabolic syndrome (MetS) is associated with BPH / LUTS. There are also numerous evidence that hypogonadism is associated with both conditions, thus being one of the most probable pathogenetic factor underlying the association between MetS & BPH / LUTS. Preliminary evidences from observational clinical studies have shown that treatment with testosterone replacement in hypogonadal patients with MetS reduces the symptoms of lower urinary tract symptoms (LUTS) associated with BPH. Preclinical studies performed by the investigators research group show in an experimental model of metabolic syndrome the occurrence of marked inflammation and tissue remodeling of the prostate gland, which is prevented by treatment with testosterone replacement (Vignozzi et al., 2012). There is therefore a need for a clinical trial to demonstrate the effect of treatment with testosterone replacement in reducing the inflammation of the prostate and its effectiveness in improving the symptoms related to inflammation in patients with prostatic BPH associated with metabolic syndrome and testosterone deficiency . The aims of the present study is to evaluate the effectiveness of testosterone replacement therapy compared to placebo in reducing signs and symptoms of inflammation of the prostate and LUTS symptoms in hypogonadal patients with metabolic syndrome and BPH who are candidates for radical prostatectomy simple. For this purpose both clinical (assessment of specific symptoms of prostatitis assessed by questionnaire National Institutes of Health Chronic Prostatitis Symptom Index, NIH-CPSI and assessment of the symptoms of LUTS and questionnaires International Prostate Symptom Score, IPSS), ultrasound (transrectal ultrasound evaluation of markers of prostatic inflammation: macrocalcifications, inhomogeneity etc.), biochemical (evaluation of inflammatory cytokines in the semen), urodynamic and histology (histomorphometric and immunohistochemical analysis of samples prostate derived from patients enrolled in the study or not treated with testosterone) scores will be performed. Along with the symptoms and clinical signs of prostate inflammation and LUTS, the effect of testosterone therapy or placebo on penile erection will be also evaluated.

NCT ID: NCT02356172 Terminated - Hypogonadism Clinical Trials

Psychological Outcomes in Isolated GnRH Deficiency

Start date: February 4, 2015
Phase:
Study type: Observational

Background: - Isolated (or Congenital) GnRH Deficiency (IGD) is a rare disease. People who have this go through puberty late. Some never reach puberty or don t complete it without treatment. They also may have an impaired sense of smell or other health problems. Research shows that disorders like this can have a negative effect on a person s psychological profile. Objective: - To understand the psychological outcomes in people with IGD. These can include depression, anxiety, poor health, and poor social function. Eligibility: - Adults age 18 and over with IGD. They must be currently on a full dose of hormone replacement therapy for at least 3 months. - Healthy adult volunteers. Design: - Participants will get a username and password. This will give them access to questions online. They can do this from any computer connected to the Internet. - Participants will log in and complete the questionnaires. There are 5 total, but they will appear as 1 continuous set of questions. Answering them takes about 1 hour or less. - The first set is about the participant s disorder. The rest ask about depression, anxiety, global health, and social function. - All answers will be used for research and to better understand reproductive disorders. Only researchers from the NIH Unit on Genetics of Puberty and Reproduction and from this study will know which answers belong to which participant.

NCT ID: NCT02310074 Active, not recruiting - Clinical trials for Idiopathic Hypogonadotropic Hypogonadism

Efficacy and Safety of Pulsatile Gonadotropin Releasing Hormone Pump Treatment in Patients With Idiopathic Hypogonadotropic Hypogonadism

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

Idiopathic hypogonadotropic hypogonadism (IHH) is the most common disorders of sex development (DSD).Therapy for IHH includes hormone replacement therapy, gonadotropin therapy and pulsed infusion of gonadotropin releasing hormone (GnRH).In the present study, we compared the different efficacy and safety of pulsatile GnRH pump therapy with combination gonadotropin therapy on fertility and sexual development in male patients with IHH.

NCT ID: NCT02274181 Completed - Clinical trials for Secondary Hypogonadism

An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration

Start date: December 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~]) 500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.

NCT ID: NCT02248701 Terminated - Clinical trials for Spinal Cord Injuries

Testosterone Plus Finasteride Treatment After Spinal Cord Injury

Start date: April 27, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether testosterone plus finasteride treatment will improve musculoskeletal health, neuromuscular function, body composition, and metabolic health in hypogonadal men who have experienced ambulatory dysfunction subsequent to incomplete spinal cord injury. The investigators hypothesize that this treatment will improve bone mineral density, enhance muscle size and muscle function, and improve body composition, without causing prostate enlargement.

NCT ID: NCT02248467 Completed - Obesity Clinical Trials

Study of the Effect of Testosterone Treatment on Metabolic Parameters and Urinary Symptoms in Bariatric Patients

Start date: May 2013
Phase:
Study type: Observational

The primary purpose of the study is to evaluate, in obese and hypogonadal patients eligible for bariatric surgery, the effect of testosterone replacement therapy in improving lower urinary tract symptoms (LUTS) assessed using the IPSS (International Prostate Symptom Score) questionnaire, compared to hypogonadal untreated subjects and eugonadal subjects.

NCT ID: NCT02240966 Completed - Metabolic Syndrome Clinical Trials

Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors

Start date: August 2014
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.

NCT ID: NCT02233751 Completed - Hypogonadism Clinical Trials

Pharmacokinetic Study of Subcutaneous Testosterone Enanthate

Start date: September 2014
Phase: Phase 1
Study type: Interventional

Evaluation of pharmacokinetics of subcutaneous testosterone enanthate