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 34 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 POIs 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 CDK46 inhibitorspalbociclib, ribociclib, and abemaciclibcombined with letrozole as neoadjuvant treatment for early estrogen-receptor positive ERHER2-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 CDK46 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.

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 estrogenprogesterone 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 womens 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 womens health. Participants are grouped by menopausal stage premenopausal with regular periods, perimenopausal with irregular periods and some menopausal symptoms, and menopausalpostmenopausal 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 womens health.

This research aims to evaluate the Antimfcllerian Hormone AMH as a predictor of infertility risk in children with cancer or benign diseases treated with chemotherapy andor pelvic irradiation. It focuses on girls aged 3 to 14 years, including prepubertal and pubertal patients, who are classified into high, moderatelow, and no risk groups based on their treatments potential impact on ovarian reserve. The study addresses the challenge of assessing ovarian reserve and fertility preservation needs in young patients who progress normally through puberty but may have impaired ovarian function due to treatment. Participants are observed over several years with no intervention administered as part of the study. They are grouped by their risk category high risk those receiving conditioning therapy for bone marrow transplantation or pelvic irradiation, moderatelow risk patients treated with chemotherapy regimens associated with varying risks, and no risk patients with benign or malignancies not involving gonadotoxic treatment. Assessments include measuring AMH levels and other hormones before and after treatment and during follow-up visits up to 18 years old. During the study, participants undergo evaluations at inclusion, end of treatment, annually for the first three years, and then every two years until age 18. These include blood tests for ovarian reserve hormones AMH, FSH, estradiol, testosterone, LH, pubertal stage assessments using TANNER criteria, menstrual cycle monitoring, and bone age evaluation via X-rays. Researchers will use these measurements to identify patients at risk of premature ovarian failure and to better understand how chemotherapy affects ovarian function in relation to pubertal status.

Researchers are studying tumors of the hypothalamic-pituitary unit in children and adults aged 2 to 70 years, aiming to understand the genetic causes and developmental pathways involved in pituitary gland tumors. This observational study also serves as a training protocol for fellows and students to learn about genetic defects, tumor recognition, management, and complications. The study includes research on new MRI tools and psychological effects of cortisol secretion in pediatric patients with Cushing disease. Participants with tumors or related hypothalamic-pituitary disorders undergo various procedures including MRI scans and tissue specimen collection. The study collects peripheral blood samples and tumor tissues for molecular genetic testing and whole exome sequencing. It also evaluates cognitive, psychological, and patient-reported outcomes related to hypercortisolemia and adrenal insufficiency in children with Cushing syndrome. Participants are assessed through imaging studies, biochemical tests, and genetic analysis. The study monitors psychological and cognitive health and collects patient-reported data on mental and social well-being. This protocol also functions as a screening platform for future clinical studies on diagnosis, treatment, and follow-up of pituitary tumors. Participation involves ongoing evaluation with no specified end date, supporting the development of new therapeutic approaches and research in pituitary tumor biology.