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Hypogonadism clinical trials

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NCT ID: NCT04733274 Active, not recruiting - Kallmann Syndrome Clinical Trials

Patient and Healthcare Professional Views on Genetic/Genomic Information and Testing

Start date: March 22, 2018
Phase:
Study type: Observational

Technologic advances (i.e. next generation sequencing technologies and novel bioinformatics approaches) have been drivers of scientific discovery and have deepened our understanding of the genetics and genomics of health and disease. In parallel, the falling cost of sequencing has led to screening moving from specialty clinics into the primary care setting. However, our ability to help patients and families understand these technologies and related genetic health literacy issues lag behind. These factors pose a number of questions and challenges for clinicians including: how can we best present complex genetic/genomic information to patients to ensure that patients understand the information and can make informed decisions? What are the specific information and support needs of patients and families to be able to make decisions that are in line with their values? In collaboration with investigators from the Harvard Reproductive Endocrine Sciences Center at the Massachusetts General Hospital, this project broadly aims to examine patient understanding and factors affecting decisions surrounding genetic testing. Using the paradigm of a rare genetic disorder (isolated gonadotropin releasing hormone [GnRH] deficiency - hypogonadotropic hypogonadism/Kallmann syndrome [HH/KS]) we will examine the views and perspectives of patients and healthcare professionals alike regarding genetic/genomic information and testing with the intention of identifying patient-centered responses to these unmet needs and challenges.

NCT ID: NCT04558567 Active, not recruiting - Hypogonadism, Male Clinical Trials

Vogelxo(R) ABPM Study in Hypogandal Men

Start date: August 28, 2020
Phase: Phase 4
Study type: Interventional

A Phase 4 ABPM study in Hypogonadal Men

NCT ID: NCT04326673 Active, not recruiting - Hypogonadism, Male Clinical Trials

Salivary Testosterone in Men: Diurnal Variation and Post-Prandial Responses

Sal T
Start date: October 30, 2020
Phase:
Study type: Observational

The purpose is to evaluate Sal-T against standard biomarkers of male gonadal status based on serum T, calculated free T and BAT. The optimal salivary sampling in terms of fasting and time of day will also be defined. The ultimate aim is to add Sal-T into the Trust's repertoire of tests in investigating suspected hypogonadism in men.

NCT ID: NCT03721497 Active, not recruiting - Clinical trials for Bariatric Surgery Candidate

Testosterone in Bariatric Patients

Start date: December 17, 2020
Phase: Phase 4
Study type: Interventional

Bariatric surgery is an effective method in the treatment of severe obesity and type 2 diabetes mellitus achieving high remission rates. However, weight loss also causes loss of skeletal muscle and bone mass which at least partly could be prevented by exercise and dietary intervention although the counselling of obese and sedentary individuals in order to increase their physical activity presents a challenge. As up to 78.8% of men undergoing bariatric surgery have low levels of testosterone, testosterone therapy could be considered an attractive alternative or supplement to prevent the immense loss of muscle mass during weight loss. Furthermore, low testosterone levels are associated with sarcopenia, insulin resistance, increased body fat, reduced quality of life, loss of libido and reduced sexual function. The study is a long-term randomized, placebo-controlled trial investigating the effects of testosterone therapy combined with exercise and diet counselling on body composition, components of the metabolic syndrome, hormones, inflammation, sexual function and quality of life before and after weight loss in obese, hypogonadal men undergoing bariatric surgery.

NCT ID: NCT02758431 Active, not recruiting - Hypogonadism Clinical Trials

Cardiovascular Outcomes of Low Testosterone

CardioVOLT
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

This study plans to learn more about heart and vascular aging in men. In some men as they get older, testosterone levels fall below the normal range for young men. Also, as men get older cardiovascular health worsens. This can lead to high blood pressure and heart disease. In this study we want to find out what causes cardiovascular health to worsen in older men. Also we want to find out what happens when testosterone levels are lowered for a short time. Specifically, we want to see if the reduction in cardiovascular health in older men with low testosterone levels is because of damage to mitochondria. Mitochondria are the main power supply of the cells in our body. The results from this study will help to understand why cardiovascular health declines in older men with low testosterone levels compared to younger men and older men who have higher testosterone levels. Knowing this information will help to develop therapies to prevent heart disease in men.

NCT ID: NCT02443090 Active, not recruiting - Clinical trials for Erectile Dysfunction

Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men

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

To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and sexual side effects.

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: NCT00700024 Active, not recruiting - Metabolic Syndrome Clinical Trials

Odense Androgen Study - The Effect of Testim and Training in Hypogonadal Men

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

The purpose of this study is to determine the effect of training and testim on Hypogonadism.

NCT ID: NCT00351416 Active, not recruiting - Healthy Volunteers Clinical Trials

Letrozole Treatment in Normal and GnRH Deficient Women

Start date: July 2004
Phase: Phase 2/Phase 3
Study type: Interventional

This research study involves the use of the drugs Letrozole, GnRH, and NAL-GLU GnRH antagonist. Letrozole is a drug that is approved by the U.S. Food and Drug Administration (FDA) for use in breast cancer treatment that has been found to block the formation of estrogen. The NAL-GLU GnRH antagonist is a drug that temporarily blocks the action of GnRH. GnRH is a hormone that the body makes that stimulates other hormones that then control the function of the ovary. The purpose is to study the effects of the administration of letrozole in women with GnRH deficiency at the same time that they receive gonadotropin-releasing hormone (GnRH). In addition, administration of letrozole and NAL-GLU GnRH antagonist in healthy women with normal menstrual cycles will be done to evaluate the role of estrogen in the control of the hormone FSH, or Follicle Stimulating Hormone, in the female reproductive cycle. A better understanding of FSH control may help in the development of new treatments for women with difficulty conceiving.

NCT ID: NCT00287586 Active, not recruiting - Atherosclerosis Clinical Trials

Testosterone Replacement in Older Men and Atherosclerosis Progression

Start date: March 2003
Phase: Phase 4
Study type: Interventional

As men grow older, their testosterone levels decrease with age. One-third of men, 70 years of age or older, have low testosterone levels. It is known that short-term testosterone replacement is safe, and can increase muscle strength and physical function, but the risks of long-term testosterone replacement in older men with low testosterone levels are incompletely understood. Atherosclerosis is characterized by thickening of the artery walls, and the narrowing of the blood vessels as cholesterol is deposited in the lining of the arteries. It is the major cause of cardiovascular disease including ischemic heart disease (heart attacks) and stroke. Although, historically, there has been a widespread perception that higher levels of testosterone might increase the risk of atherosclerosis, the evidence from research does not support this. In observational studies, higher testosterone levels have been correlated with more favorable cardiovascular risk factors, and supplementation with testosterone to bring older men into the normal range for healthy younger men appears to improve several cardiovascular risk factors, and may slow the progression of atherosclerosis. The primary purpose of this study is to look at the effects of testosterone replacement on the progression of atherosclerosis in older men. This study is also being done to find out whether replacement with testosterone in older men with low testosterone levels improves their health-related quality of life.