Actively Recruiting
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
Led by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Updated on 2026-05-27
185
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying hormone replacement therapy (HRT) in female adolescents aged 11 to 19 years who have premature ovarian insufficiency (POI), a condition causing absent or irregular menstrual cycles and symptoms like infertility and osteoporosis. The study aims to find the most effective HRT doses and regimens for adolescents and to evaluate their bone, cardiovascular, metabolic, muscle, psychological, and menopausal health compared to healthy controls. Genetic profiling and quality of life assessments are also included. Participants with POI will receive transdermal estrogen patches starting at 25 micrograms weekly, with doses increasing over two years, and oral progesterone pills as needed. Healthy female volunteers will not receive treatment but will be assessed for comparison. All participants will attend clinic visits every six months for two years, undergoing various tests including blood and urine work, heart and blood vessel function tests, grip strength, bone density scans, skin pigmentation measurement, and optional vaginal exams. Throughout the study, researchers will monitor bone mineral density, cardiovascular and metabolic health, muscle strength, genetic background, psychological well-being, and menopause-related changes. Outcome measures include bone density of the lumbar spine and other skeletal sites, heart function, arterial stiffness, coagulation, depression and anxiety symptoms, and quality of life questionnaires. The study involves detailed assessments at visits lasting up to two days, with long-term follow-up over two years.
CONDITIONS
Brief Title
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 11 to 19 years at enrollment
- Diagnosis of premature ovarian insufficiency (POI) for POI group
- At least one elevated serum FSH measurement above age/Tanner stage reference range for POI group
- Identify as female (sex assigned at birth)
- Negative pregnancy test
- Healthy volunteers must be female, aged 11 to 19 years, with no known chronic disease and a negative pregnancy test
You will not qualify if you...
- Male participants are excluded
- Pregnant participants are excluded
- POI participants with Turner syndrome are excluded
- Patients with celiac disease are excluded
- Use of medications affecting bone metabolism within 3 months prior to enrollment
- Medical conditions affecting bone health
- Medical, psychiatric, or social conditions that increase risk or burden
- Sexual activity without agreement to use copper intrauterine device or double barrier contraception
- Healthy volunteers excluded by same criteria except Turner syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 years
Participants with premature ovarian insufficiency receive hormone replacement therapy with transdermal estrogen patches and oral micronized progesterone. Dosage adjustments are guided by clinical presentation over the course of treatment.
Regular visits for hormone dose adjustments and health assessments during the 2-year treatment period
Duration - Up to 2 years including during and after treatment
Participants are monitored longitudinally for bone health, metabolic and cardiovascular parameters, muscle function, psychological health, menopausal profile, and quality of life.
Periodic visits for assessments including bone density scans, metabolic tests, cardiovascular evaluations, psychological questionnaires, and quality of life surveys over 2 years
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
C
Catherine M Gordon, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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