185
Participants
Start Date
July 17, 2025
Primary Completion Date
December 1, 2031
Study Completion Date
December 31, 2031
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.
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).
RECRUITING
National Institutes of Health Clinical Center, Bethesda
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH