NCT07010146View on ClinicalTrials.gov

Role of Estrogen on Skeletal Outcomes in FHA

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

January 1, 2030

Study Completion Date

July 1, 2030

Conditions
Bone StrengthBone DensityFHA (Functional Hypothalamic Amenorrhea)
Interventions
DRUG

transdermal 17β-E2 with cyclic progestin

100-mcg transdermal 17β-E2 patch (to be applied twice weekly) (continuous use), with 200 mg micronized progesterone given for 12 days of every month

DRUG

oral 17β-E2 with cyclic progestin

2 mg of oral 17β-E2 pills daily, with 200 mg micronized progesterone given for 12 days of every month

DRUG

transdermal EE+LNG

transdermal EE (30 mcg) + LNG (120 mcg) contraceptive patch (TWIRLA). Patch will be applied once a week for 3 consecutive weeks, with the 4th week off the patch (to be repeated after 4 weeks).

Trial Locations (1)

22903

University of Virginia Medical Center, Charlottesville

All Listed Sponsors
collaborator

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

NIH

lead

University of Virginia

OTHER