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Showing 1-20 of 186 trials
NCT01511588
Background: \- The body produces gonadotropin-releasing hormone (GnRH) about every 2 hours. GnRH travels through the bloodstream to the pituitary gland, where it stimulates the gland to produce hormones called gonadotropins. These hormones stimulate the testicles or ovaries. The testicles produce testosterone and develop sperm. The ovaries produce estrogen and prepare for ovulation. Normal estrogen and testosterone levels are required for puberty. Some people, however, have either low levels or total lack of GnRH. This can cause problems with puberty and fertility. Researchers want to study people with low or no GnRH to better understand how it affects puberty and fertility. Objectives: \- To study disorders of GnRH production. Eligibility: * Adult men and women at least 18 years of age with low or no gonadotropin levels. * Adolescents between 14 and 18 years of age with low or no gonadotropin levels. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants will have tests to look at their hormone levels. Blood samples may be collected after taking different drugs, including insulin and cortisone. A 24-hour urine sample will be collected. * Participants will have imaging studies to look at bone and brain development. They will also have ultrasounds of the kidneys, abdomen, and reproductive organs. * Tests of smell and hearing will be used to look for abnormalities in these senses.
NCT07460726
This study looks at how combined radiation and hormone therapy affects sexual function in men with a specific type of prostate cancer, before and after treatment.
NCT07450521
A randomized, double-blind, placebo-controlled, study to assess the safety, tolerability, and PK of MTX-463 when administered via SC injection in healthy adult males.
NCT05294588
This is a double-blind randomized controlled trial to test whether the group B meningitis vaccine 4 component Neisseria meningitidis serogroup B vaccine (BEXSEROTM) (4C-MenB), trade name Bexsero™), currently approved for use by the United States Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention (CDC) for protection from Neisseria meningitidis infections, also protects from Neisseria gonorrhoeae infection using controlled human experimental infection to test protection. The information the investigator learn by doing this study may also help to develop a vaccine that protects individuals from having gonorrhea infection. The study population will consist of male participants \> 18 and \< 36 years old, living in central North Carolina, in general good health without a history of 4C-MenB vaccination. Approximately 120-140 participants will be enrolled. Participants will receive 2 doses of vaccine (2 doses of 4C-MenB or 2 comparator vaccines- seasonal influenza and tetanus/diptheria booster) as intramuscular injections, and then one intraurethral challenge with Neisseria gonorrhoeae. Following the challenge, participants will cross-over and receive two doses of vaccines not received prior to challenge (2 doses of 4CMenB or the 2 comparator vaccines- seasonal influenza and tetanus/diptheria booster) All participants receive all vaccinations by the end of the study and all vaccines used in this study are licensed and FDA-approved.
NCT05903859
This is a study of infertility which often occurs in men with spinal cord injury. Most men with spinal cord injury have a normal sperm count but abnormally low sperm motility - which means that the sperm does not swim well. This study will determine if a medicine given by mouth will improve sperm motility in men with spinal cord injuries. The medicine is called probenecid.
NCT07251153
The purpose of this study is to define and compare the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EYP651 at two dose levels and compare it with Vonafexor Acid PK and PD profile, the Part A. In addition, Part B of the trial will assess the Drug-Drug Interactions (DDI) potential with the high dose of EYP651.
NCT06019182
This observational natural history study will follow individuals with MEHMO (Mental disability, Epileptic seizure, Hypopituitarism/Hypogenitalism, Microcephaly, Obesity) syndrome or an eIF2-pathway related disorder, who have symptoms such as intellectual delay, seizures, abnormal hormone and blood sugar levels, and decreased motor skills. No current treatment for these conditions is available. A major impediment to the testing of potential therapeutic interventions is the lack of well-defined outcome measures. This protocol seeks to identify biochemical and clinical markers to monitor disease progression, and better understand the natural history of these conditions. Any person diagnosed with MEHMO syndrome or related conditions, who can travel to the NIH Clinical Center can participate in this study. The study involves: * General health assessment and evaluation * Imaging studies * Laboratory tests * Collection of blood, urine, spinal fluid, skin biopsy.
NCT06689085
This is a 52-week open label single arm study + 24-Month long-term safety extension to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism. The study aims to determine the effectiveness of XYOSTED measured by continuation or induction of puberty in addition to XYOSTED dosage, safety and testosterone levels.
NCT04731376
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.
NCT07364409
For pre-pubertal boys undergoing gonadotoxic therapies, freezing immature testicular tissue (ITT) containing spermatogonial stem cells (SSCs) is currently the only option to potentially preserve future fertility. This experimental clinical study aims to provide proof-of-concept that frozen-thawed, ectopically autotransplanted adult human testicular tissue can support spermatogenesis in healthy adult men.
NCT07361120
Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then be reversed to subsequently allow the passage of sperm through the vas deferens.
NCT07322991
The purpose of this stud is to evaluate the drug-drug interaction between IY001 and IY002 in adult males.
NCT05960682
Sexual dysfunction consists of a disorder of the sexual response, either in terms of desire, or in terms of vasocongestion, or in terms of orgasmic response, or in more than one phase of this response : Sexual dysfunctions are today described by the Diagnostic and Statistical Manual (DSM) V as: * Disorders of sexual desire or decreased libido * Sexual arousal disorder * Delayed or absent orgasmic disorder * Sexual disorder with pain Moreover, sexual dysfunctions are not without consequences on the life of a couple. The origins of these dysfunctions are multiple, but the result is most of the time the same: fear of failure, feeling of incompetence, anxiety, frustration or misunderstanding. To date, the scientific community benefits from a few self-administered questionnaires to measure the impact of certain dysfunctions. None takes into account all the dimensions of male sexuality. In Italy, the Brief Index of Sexual Functioning for Men is used. This questionnaire contains 22 items, grouped into 7 areas exploring all of male sexuality: desire, arousal, frequency of activity, receptivity, pleasure/orgasm, relationship satisfaction, problem affecting sexuality. This questionnaire is not currently validated in French, whereas the Brief Index of Sexual Functioning for Women is validated.
NCT05245669
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male volunteers.
NCT06191575
This study evaluates 7 Tesla (T) magnetic resonance imaging (MRI) in observing changes in the brain (neuroimaging) in testicular cancer patients who have decreased testosterone (hypogonadism) and are on testosterone (androgen) replacement therapy. Symptoms of hypogonadism can include fatigue, weakness, loss of libido, depression, poor concentration and erectile dysfunction. Some patients experience mental changes after diagnosis and treatment. There is some evidence that hypogonadism produces structural changes in the brain. The 7T MRI uses radio waves and a very powerful magnet linked to a computer to create detailed pictures of areas inside the body. This study may help researchers learn if 7T MRI can produce better images to assess the changes in the brain structure of testicular patients with hypogonadism and on androgen replacement therapy (ART).
NCT07295314
The goal of this clinical trial is to learn how the antifungal drug fluconazole affects the gut microbiome and immune system in healthy volunteers. The main questions it aims to answer are: * Does fluconazole change the gut bacteriome and mycobiome composition after 14 days of treatment? * How long do these changes last (4 weeks and 6 months after treatment)? * Does fluconazole affect the body's immune responses, such as blood cell activity and antifungal antibodies? Researchers will compare two groups: participants who take fluconazole for 14 days and participants who receive no intervention. Participants will: * Either take one fluconazole tablet (200 mg) daily for 14 days, or receive no treatment * Provide stool samples and blood samples at several timepoints * Return for follow-up visits up to 6 months after treatment This study is conducted at Amsterdam UMC, location AMC, with a planned enrollment of 50 healthy male volunteers aged 18-35 years.
NCT06910332
This randomized, double-blind study examines the acute effects of shoulder mobilization on muscle strength and proprioception in healthy individuals. Forty-eight participants (aged 18-25) were randomly assigned to either a mobilization or sham intervention group. Muscle strength and proprioception were assessed before and after treatment. The mobilization group received passive shoulder joint glides, while the sham group underwent a placebo procedure. The study aims to determine whether mobilization affects strength and proprioception immediately.
NCT07269873
Naltrexone (NTX), an opioid receptor antagonist, has a longstanding history of safe and effective use for the treatment of addictive disorders. NTX is available in several forms, such as daily oral tablets (Revia®) and sustained release monthly injections (Vivitrol®). BioCorRx Pharmaceuticals is currently developing a subcutaneous implantable pellet drug product, BICX104, which contains NTX base anhydrous (997.5 mg) and can be administered via a minor surgical procedure. BICX104 is anticipated to provide plasma concentrations of ≥ 1 ng/mL NTX for 3 months. Subjects will be enrolled in 4 sequential cohorts and followed for a total of 196 days, comprising an 84-day treatment period, an 84-day follow-up period, and a 28-day post-treatment follow-up period. While therapeutic levels of naltrexone ( ≥ 1 ng/mL plasma concentration) are expected to be maintained throughout the treatment period, intermittent PK sampling will continue through Day 196, at which all subjects are expected to achieve NTX levels below the level of quantitation (BLQ). Safety parameters include assessment of adverse events, vital signs, laboratory parameters, ECG data, and the Columbia Suicide Severity Rating Scale (C-SSRS), and will continue through the final safety visit at Day 196. A total of 30 healthy normal volunteers will be enrolled sequentially in the following cohorts, listed in sequence: 1. One BICX104 (1.0 g NTX) implantable pellet (n = 8) 2. One BICX104 implantable pellet with 450 mg QD bupropion XL (n = 8) 3. Two BICX104 implantable pellets with 450 mg QD bupropion XL (n = 8) 4. Three consecutive Vivitrol 380 mg injections Q28 days (n = 6) Enrollment will be stratified by biological sex (50% females and 50% males in each cohort) Subjects will participate in 18 clinic visits over 31 weeks comprising the 3-week screening period, 12-week treatment period, 12-week follow-up period, and 4-week safety follow-up period. The test products will be BICX104 implantable pellets (dosage: 1 or 2 implants q. 12 weeks), Bupropion XL (dosage: 450 mg QD) BICX104 will be supplied to the clinical research site in appropriately labeled closed containers; bupropion XL will be supplied in its standard commercial packaging configuration. The comparator product will be Vivitrol® IM injection (380 mg NTX) (dosage: 1 injection q. 4 weeks) Vivitrol® will be supplied in its standard commercial packaging configuration. The study assessments will be as follows: After all screening assessments and the 24-hour Treatment Initiation Visit, safety and PK assessments will occur on Days 3, 5, 7, 14, 21, 28, 42, 56, 70, 84, 98, 112, 126, 140, 154, and 168. Final safety assessments will occur on Day 196. The Treatment Initiation Visit will involve 1 overnight stay and include PK sampling at pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 hours post-dose, in addition to safety assessments. Safety assessments will include clinical chemistry, hematology, vital signs, physical exam, ECGs, and administration of the Columbia Suicide Severity Rating Scale (C-SSRS).
NCT06840080
A placebo controlled, single blind, cross-over study evaluating the short-term effect of oleoylethanolamide (OEA) with LipiSperse supplementation on metabolic pathways in healthy participants.
NCT03093909
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have spread to the lungs from other parts of the body. The safety and side effects of this drug will also be studied. This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic and lung cancer, and other solid tumors. Its administration by inhalation is investigational. The study doctor can explain how the study drug is designed to work. Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.