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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: 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: 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: NCT04717362 Withdrawn - Infertility, Male Clinical Trials

The Effects of Natesto For Treatment Of Hypogonadism

Start date: March 1, 2024
Phase: Early Phase 1
Study type: Interventional

In this prospective study, the investigators plan is to confirm the role of Natesto (intranasal testosterone) to combat hypogonadal symptoms in men trying to recover spermatogenesis following the withdrawal of conventional Testosterone replacement therapy.

NCT ID: NCT04708249 Completed - Sexual Dysfunction Clinical Trials

D-chiroinositol Administration in Hypogonadal Males

Start date: January 18, 2021
Phase: N/A
Study type: Interventional

D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several works have reported the influence of DCI on steroidogenesis. In particular, the DCI capabilities to regulate aromatase expression and testosterone biosynthesis are arising. In this regard, DCI administration in case of reduced levels of testosterone, could be a good therapeutic opportunity. For this reason, the treatment of Late-Onset Male Hypogonadism (LOH) in undoubtedly an interesting target. LOH is a reduction of testosterone level due to advancing age, currently treated with Testosterone Replacement Therapy (TRT). Unfortunately, there is a lack of information about TRT safety, especially in older men. For these reasons, the aim of this study is to evaluate the effect of DCI treatment on testosterone accumulation in LOH patient.

NCT ID: NCT04704141 Not yet recruiting - Male Infertility Clinical Trials

Relationship of the Microenvironment and Male Fertility

Start date: June 2023
Phase:
Study type: Observational

Although much is known about the microenvironment of the gut and the vagina, very little has been published on the microenvironment of the seminal plasma. The seminal plasma is the support fluid for sperm, providing nutrients, facilitating sperm transit to the uterus, and promoting fertilization. It is a rich area of research for markers of fertility and treatment targets. The investigators hypothesize that (1) there are significant populations of seminal microorganisms associated with seminal leukocyte counts well below the WHO's cutoff for pyospermia (1 million/mL) that were not previously detected by traditional culturing methods, and (2) there are pathologic populations of bacteria within the gut and semen microbiome which negatively impact overall fertility, by directly or indirectly impairing hormone status. Participants will be recruited from the Male Fertility practice at the University of Illinois-Chicago (UIC). All participants will have infertility, diagnosed as an inability to conceive pregnancy after 12 months of unprotected intercourse. The normal evaluation of these participants is to obtain at least one semen analysis and bloodwork investigating their endocrine profile: total testosterone, estradiol, sex hormone binding globulin (SHBG), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and albumin. Semen volume is typically >1 mL, and <0.2 mL is typically used for the semen analysis. If over 1 million/mL round cells are identified, then a Papanicolaou stain would be performed to identify leukocytes. In this study, any semen demonstrated to have round cells would undergo Papanicolaou staining. A portion of the remaining semen, which would typically be discarded, will be sent for microbiome analysis. Secondly, as part of routine care, fertility patients may be started on medications to increase endogenous testosterone (i.e.: clomiphene citrate, anastrozole, etc). Participants started on medications will also be asked to submit a rectal swab for gut microbiome analysis. Routine care is to monitor the hormonal and testicular response with periodic endocrine blood panels and semen analyses; rectal swabs will be requested at these follow-up intervals also. The control group for both hypotheses will be men with clinical infertility with normal semen analyses and hormone profiles.

NCT ID: NCT04673682 Completed - Hypogonadism Clinical Trials

A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-845

Start date: November 16, 2020
Phase: Phase 1
Study type: Interventional

A clinical trial to evaluate the pharmacokinetic profiles and safety of CKD-845.

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.