Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

July 17, 2025

Primary Completion Date

December 1, 2031

Study Completion Date

December 31, 2031

Conditions
Premature Ovarian Insufficiency
Interventions
DRUG

Progesterone

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.

DRUG

Estrogen Patch

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).

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH