Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency

Conditions

• Premature Ovarian Insufficiency

Eligibility Criteria

Sex

FEMALE

Age

11 Years - 19 Years

Healthy Volunteers

Accepted

Interventions

• Progesterone — DRUG
  Oral micronized progesterone will be added (100 mg/day for 12 days/month) in the event of spontaneous vaginal bleeding and/or at 12 months over the 2-year protocol.
• Estrogen Patch — DRUG
  participants with POI (n=85) will receive transdermal 17 beta-estradiol (beginning at a dose of 25 microgram/patch applied weekly), with the dose increased at 3 months to 50 microgram, and thereafter every 6 months to 75 and 100 microgram/patch for pubertal induction or estrogen replacement (with 100 microgram/patch representing a full adolescent or young adult estradiol dose). The continued escalation of the estradiol dose and patch strength will be guided by the clinical presentation and physical examination (by the PI or designated AI).

Study Details

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.

Key Dates

Start date

Jul 17, 2025

Status verified

May 2026

Primary completion

Dec 1, 2031

Completion

Dec 31, 2031

Study Design

Enrollment

185 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Healthy Participants
  Healthy Control Participants
• Experimental: POI Patients
  POI patients will be receiving transdermal 17 beta-estradiol and oral micronized progesterone.

Primary Outcome Measure

Longitudinal evaluation of BMD of the central skeleton (lumbar spine). [ Time Frame: 2 years ]

Central Contacts

• Catherine M Gordon, M.D.
  (301) 827-5449
  [email protected]

Locations (1)

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