Hypogonadism

Researchers are evaluating the use of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years with primary or secondary hypogonadism, a condition where the body produces little or no testosterone. This Phase 3/4 open-label study aims to assess how well XYOSTED supports the continuation or start of puberty, along with its safety and the testosterone levels it maintains. Participants will receive XYOSTED injections at doses tailored to their weight and targeted pubertal stage. Dose adjustments will be made based on testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach the desired hormone levels. After completing the 52-week initial study period, participants may enter a 24-month extension to further monitor long-term safety and treatment effects. Throughout the study and extension, participants will undergo clinical examinations including pubertal staging, blood tests for testosterone and other labs, bone density scans, body composition assessments, and X-rays to monitor bone age. Researchers will track changes in puberty progression, bone health, body measurements, and hormone levels. Participants will attend regular clinic visits every six months during the extension phase to continue safety and pharmacokinetic evaluations.

Premature ovarian insufficiency (POI) occurs when ovarian function declines in women before age 40, significantly affecting health and quality of life. This research aims to better understand the causes, progression, and health impacts of POI, as well as evaluate hormone replacement therapy (HRT) options. The study will create a hospital-based, multi-center case-control and prospective cohort to gather comprehensive data on POI's natural course and effects. The study includes several groups: women diagnosed with POI, control women with regular menstrual cycles, those scheduled for ovarian surgery, and those undergoing oophorectomy. Participants provide biological samples, lifestyle and health information, and undergo long-term follow-up assessments. Data collection spans multiple health factors including reproductive hormones, bone density, psychological well-being, and metabolic markers. Participants will be monitored at regular intervals up to 36 months with tests such as bone density scans, hormone level checks, blood glucose and insulin measurements, and psychological assessments for anxiety and depression. The study also tracks symptoms related to low estrogen and sexual health. Safety and health outcomes are observed through blood counts, liver and kidney function tests, and ultrasound exams. This comprehensive approach aims to deepen understanding and support improved care for women with POI.

This research investigates a new self-administered digital application designed to improve sexual health, quality of life, and psychological distress among survivors of hematopoietic stem cell transplants (HCT). HCT survivors often face long-term sexual dysfunction due to complex biological, psychological, and social factors, which significantly affect their well-being and relationships. The study aims to address these challenges through a multidisciplinary approach delivered via a digital platform. Participants will be randomly assigned to either use the SHIFT digital application or receive enhanced usual care. The SHIFT app includes interactive features like gamification, survivor videos, intimacy exercises, and optional content to engage users over eight weeks. Those in the usual care group will meet with their clinicians and may be referred to specialists if needed but will not have access to the SHIFT app. During the study, participants will complete assessments measuring sexual satisfaction, function, quality of life, anxiety, and depression at various points up to 24 weeks. Researchers will monitor global satisfaction with sex at week 8 as the primary outcome. The study involves medical evaluations and tracks psychological and physical health through questionnaires and scales, aiming to evaluate the impact of the digital intervention on sexual health outcomes and overall well-being in HCT survivors.

Researchers are evaluating and comparing the immune modulation effects of three FDA-approved CDK4/6 inhibitors—palbociclib, ribociclib, and abemaciclib—combined with letrozole as neoadjuvant treatment for early estrogen-receptor positive (ER+)/HER2-negative breast cancer. While all three inhibitors have shown progression-free survival benefits in advanced breast cancer, differences in overall survival might be influenced by their varying effects on the tumor microenvironment and immune system. This Phase 2 randomized study aims to provide a head-to-head comparison of these effects in the same trial. Participants will receive one of three treatment combinations: palbociclib with letrozole, ribociclib with letrozole, or abemaciclib with letrozole. These CDK4/6 inhibitors are given alongside endocrine therapy before surgery over a 12-week period. Tissue, blood, and stool samples will be collected before treatment, two weeks after starting treatment, and after 12 weeks at surgery to analyze immune-related changes through RNA sequencing of breast tumors. During the study, researchers will monitor participants for immune response changes and adverse events. The primary outcome is the change in immune-related gene expression after treatment, assessed through RNA sequencing over an average follow-up of three years. Safety will be assessed over four months. Participants’ organ function and performance status will be evaluated before and during treatment to ensure safety and compliance with study procedures.

This research evaluates the use of low-intensity shockwave therapy (LI-SWT) as a treatment for men with erectile dysfunction (ED), a condition where it is difficult to achieve or maintain an erection firm enough for sex. The study aims to gather information on which patients benefit from this therapy to better predict outcomes and help guide treatment decisions. The device used has FDA clearance but is not yet approved specifically for ED treatment. Participants will receive six weekly sessions of LI-SWT using the UroGold100™ device, which applies shockwave energy to the penis and perineum. Before treatment, patients complete questionnaires, blood tests, and a non-invasive blood vessel function test with the EndoPAT device. Follow-up visits occur at 3, 6, and 12 months after the initial baseline visit, including additional questionnaires and safety surveys. During the study, researchers will monitor erectile function using the International Index of Erectile Dysfunction-Erectile Function Domain (IIEF-EFD) score, focusing on changes three months after treatment and durability of improvement at six and twelve months. Safety and any adverse effects will be assessed throughout. Total study participation includes baseline assessments, treatment sessions, and follow-up evaluations over one year.

Researchers are evaluating a new treatment called ST-04, a mucoadhesive intraurethral polymer suspension of alprostadil, for adult males with erectile dysfunction (ED). This Phase 2 trial aims to assess the effectiveness of three different dose levels of ST-04, with or without sildenafil, to improve erectile function compared to the participants' baseline. ST-04 is designed to deliver alprostadil directly inside the urethra to promote penile tumescence and erection. Participants will receive up to three escalating doses of ST-04 over a 12-week period, with a maximum of 11 administrations. Dose levels include 500 mcg, 1000 mcg, and 1500 mcg of ST-04, which may be given with or without sildenafil. Each dose is dispersed along the urethra forming a hydrogel that adheres to the lining to achieve its effect. During the study, participants will undergo assessments including the International Index of Erectile Function (IIEF) questionnaire to measure changes in erectile function at baseline and 1 month after each dose level. Additional evaluations include the Erectile Hardness Scale, Sexual Encounter Profile, and the percentage of successful erection onset within 30 minutes of application. Safety will be monitored through the recording of adverse events. The total study duration includes up to 12 weeks of treatment with regular follow-up visits.

This research aims to evaluate if men can appropriately select and use tadalafil 5 mg tablets as an over-the-counter (OTC) treatment for erectile dysfunction. The study is an open-label actual use trial enrolling about 2,250 men who have symptoms of erectile dysfunction and are interested in OTC treatment. Approximately 1,000 participants are expected to proceed to the use phase based on their responses to a mandatory health survey assessment. Participants will take tadalafil 5 mg tablets orally, one tablet daily, while using a digital health survey tool. The study is conducted remotely via video interaction over a four-month period. It is designed as a single-arm open-label trial, focusing on real-world use of tadalafil as an OTC medication. During the study, researchers will monitor how well participants follow the recommended dosing intervals, their medical conditions, and any adverse events or care-seeking behaviors related to the use of tadalafil. Participants will complete health surveys, record their dosing and symptoms in electronic diaries, and be monitored for safety throughout the 4-month use phase plus a 30-day follow-up period. The main outcomes include adherence to dosing recommendations and appropriate use based on medical assessments.

Non-combat-related muscle, tendon, and bone injuries are common among military personnel, especially new recruits, affecting readiness and causing significant medical costs. This research investigates how hormonal changes, specifically sex hormones like testosterone and estrogen, influence muscle, tendon, and bone function as well as physical and psychological performance under stress. The study aims to improve military physical training and reduce injuries by understanding these hormonal effects. Participants will be assigned to different groups including a control group maintaining normal habits and a stress exposure group undergoing a 4-week military-style physical training program. Some men and women in the stress group will receive medications to suppress natural hormone production and then receive hormone replacement or a placebo. Treatments include a GnRH agonist injection and topical testosterone gels or estrogen/progesterone patches, with dosing varying by group and sex. Throughout the approximately 8-week study, participants will undergo measurements such as muscle and tendon imaging, body composition analysis, blood tests for hormone and biochemical markers, and physical and mental performance evaluations. Researchers will monitor changes in these outcomes over time to assess the effects of hormone suppression and replacement on musculoskeletal resilience and adaptation to stress.

Researchers are studying how changes in the gut microbiome relate to hormonal changes during women's ageing, especially throughout menopause. This observational study focuses on healthy women aged 40 to 64 living in Portugal. It aims to understand how menopause affects long-term health by examining gut microbiome, hormone levels, and markers of chronic low-grade inflammation, to help develop better prevention strategies for women's health. Participants are grouped by menopausal stage: premenopausal with regular periods, perimenopausal with irregular periods and some menopausal symptoms, and menopausal/postmenopausal with no menstruation for 12 months. Women will provide stool and blood samples and complete questionnaires about their health, lifestyle, diet, and menopausal symptoms. The study collects data over 10 years, with baseline and follow-up assessments every two years. During the study, participants will be assessed for gut microbiome composition and function, hormone levels, inflammation markers, menopause-related symptoms, nutrition, physical activity, sleep habits, and stress levels. These evaluations help researchers identify microbiome and blood biomarkers linked to menopause and ageing. Participation involves regular sample collection and questionnaires, with ongoing monitoring to support personalized risk assessment and prevention in women's health.

Researchers are studying how Antimüllerian Hormone (AMH) levels can predict the risk of future infertility in girls aged 3 to 14 who are undergoing cancer treatment or treatment for benign diseases. The goal is to identify young patients who may have a reduced ovarian reserve after treatment and could benefit from special follow-up or fertility preservation. The study includes children at high, moderate/low, or no risk of ovarian damage from chemotherapy or pelvic irradiation. The study observes AMH and other hormone levels before and after treatment, with no interventions applied. Participants are grouped by their risk level: high risk patients receiving conditioning therapy or pelvic irradiation; moderate/low risk patients treated with chemotherapy regimens for various cancers; and a control group with no risk, consisting of patients with benign diseases or cancers not requiring gonadotoxic treatment. Assessments occur at diagnosis, treatment end, and during follow-up visits scheduled yearly for three years, then every two years until age 18. Participants will have their ovarian reserve evaluated through hormone tests including AMH, FSH, estradiol, testosterone, and LH, alongside menstrual cycle tracking and pubertal development assessed annually using Tanner staging and bone age X-rays. The primary outcome is the AMH marker measured regularly up to 18 years old. Secondary outcomes include premature ovarian failure and ovarian reserve changes. The study also monitors oncological outcomes as per standard care, with a total follow-up duration extending to 18 years old.