Hormone Replacement Therapy Study for Female Adolescents Aged 11 to 19 With Premature Ovarian Insufficiency

What this Trial Is About

Premature ovarian insufficiency POI is a condition in which females under 40 years have absent or irregular menstrual cycles, leading to infertility, menopause symptoms, and bone health issues. This research evaluates hormone replacement therapy HRT in adolescent females aged 11 to 19 years with POI, aiming to find the most effective doses and regimens. The study is a phase 3 interventional trial comparing adolescents with POI to healthy female controls to understand bone, metabolic, cardiovascular, muscle, genetic, psychological, and menopausal health effects. Participants with POI will receive transdermal 17 beta-estradiol patches starting at 25 micrograms weekly, with dose escalation every 3 to 6 months up to 100 micrograms for estrogen replacement or pubertal induction. Oral micronized progesterone may be added for 12 days per month if vaginal bleeding occurs or after 12 months. Healthy volunteers will not receive treatment but will participate as controls. The study lasts 2 years with regular clinical evaluations. During this 2-year study, participants will attend clinic visits every 6 months that may last up to 2 days. Assessments include blood and urine tests, heart function tests, arterial stiffness measurement, grip strength, and bone density scans at multiple skeletal sites. Additional measures include skin pigmentation, vaginal exams, genetic profiling, and questionnaires on quality of life and psychological health. Researchers will monitor bone mineral density, metabolic and cardiovascular health, muscle function, menopausal symptoms, and response to HRT over time.

Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency