NCT06851754 Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
| NCT ID | NCT06851754 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Condition | Premature Ovarian Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 185 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2031-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 185 participants in total. It began in 2025-07-17 with a primary completion date of 2031-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Premature ovarian insufficiency (POI) is a condition in which women under the age of 40 years have absent or irregular menstrual cycles. POI can cause infertility, signs of menopause, osteoporosis, and other symptoms. Hormone replacement therapy (HRT) is a treatment that gives women extra hormones, such as estrogen and progesterone. HRT works well in adult women. Researchers want to find the most effective doses and regimens for adolescents. Objective: To monitor the effects of HRT on adolescents with POI. Eligibility: Female adolescents aged 11 to 19 years diagnosed with POI. Healthy volunteers are also needed. Design: All participants will have clinic visits every 6 months for 2 years. Each visit may last 2 days. Each visit may include: Blood and urine tests. A test of their heart function. A test to measure the stiffness of their blood vessels. Participants will lie flat with a blood pressure cuff on a leg and a meter on the neck while the cuff inflates. A test of their grip strength. Participants will squeeze a handheld device as hard as they can. Two scans to measure bone density. For one, participants will lie on a table while a scanner passes along their body. For the other, participants will sit in a chair and insert their forearm, then their lower leg, into a scanner. A test to measure skin pigmentation. Participants' skin will be touched lightly with a device. An optional visual exam of the vagina. Some vaginal fluid may also be collected with a cotton swab/cytobrush. Participants with POI will receive HRT. They will be given estrogen patches and progesterone pills.
Eligibility Criteria
* INCLUSION CRITERIA: Inclusion Criteria for POI Participants To be eligible to participate in this study, an individual must meet all the following criteria: 1. Individuals aged 11-19 years, inclusive, at the time of enrollment. 2. Diagnosis of premature ovarian insufficiency. 3. Documentation of one elevated serum FSH measurement greater than the testing laboratory's upper reference range (for age/Tanner stage). 4. Identify as female (i.e., sex assigned at birth) 5. Negative pregnancy test. Inclusion Criteria for Healthy Volunteers: 1. Individuals aged 11-19 years. 2. Identify as female (i.e., sex assigned at birth) 3. Negative pregnancy test. 4. Absence of known chronic disease EXCLUSION CRITERIA: Male participants are excluded from both study groups (POI and Healthy Volunteers) as POI affects only the female reproductive system, while pregnant participants are not eligible to have DXA or HRpQCT imaging for safety reasons. Exclusion Criteria for POI participants: An individual who meets any of the following criteria will be excluded from participation in this study: 1. POI in the setting of Turner syndrome. 2. Patients who screened positive for celiac disease. 3. Receipt of any medications including HRT determined by the investigator to affect bone metabolism 3 months prior to enrollment. 4. Any medical condition determined by the investigator to affect bone health will be excluded. 5. Presence of a medical, psychiatric, or social condition which, in the opinion of the investigator, would place undue burden on the subject, NIH resources, or increase risk of participation. 6. Report of sexual activity but refusal to use a copper intrauterine device or double barrier forms of contraception during the study. Exclusion Criteria for Healthy Volunteers: For healthy volunteers, all exclusion criteria will apply as for POI participants except for number 1.
Contact & Investigator
Catherine M Gordon, M.D.
PRINCIPAL INVESTIGATOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Frequently Asked Questions
Who can join the NCT06851754 clinical trial?
This trial is open to female participants only, aged 11 Years or older, up to 19 Years, studying Premature Ovarian Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06851754 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 185 participants.
Is NCT06851754 currently recruiting?
Yes, NCT06851754 is actively recruiting participants. Contact the research team at catherine.gordon@nih.gov for enrollment information.
Where is the NCT06851754 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06851754 clinical trial?
NCT06851754 is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The principal investigator is Catherine M Gordon, M.D. at Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The trial plans to enroll 185 participants.