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Role of Estrogen on Skeletal Outcomes in FHA
Sponsor: University of Virginia
Summary
The purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen (17-beta estradiol) taken by mouth, or a synthetic form oestrogen (ethinyl estradiol) given as a patch that also provides birth control. Participants will: 1. Take estrogen for 1 year either (i) in its natural form as a patch twice a week (and progesterone by mouth for 12 days of each month), or (ii) in its natural form as a pill daily (and progesterone by mouth for 12 days of each month), or (iii) in a synthetic form as a birth control patch weekly for 3 weeks with 1 week off the patch. You will not be able to choose which form of estrogen you will receive as this will be assigned to you based on a pre-existing randomization sequence (like the flip of a coin) 2. Take provided calcium and vitamin D supplements 3. Attend 4 study visits over 12 months with two at the beginning and then every 6 months that include: * History and Physical Exams * Lab Work * Imaging studies * Questionnaires * Dietary recalls
Official title: Role of Estrogen Formulation and Route of Delivery on Skeletal Outcomes in Functional Hypothalmic Amenorrhea
Key Details
Gender
FEMALE
Age Range
14 Years - 30 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-07-01
Completion Date
2030-07-01
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
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
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
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).
Locations (2)
University of Virginia Medical Center
Charlottesville, Virginia, United States
University of Virginia
Charlottesville, Virginia, United States