Role of Estrogen on Skeletal Outcomes in FHA

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07010146
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bone Density
  • Bone Strength
  • FHA (Functional Hypothalamic Amenorrhea)

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • transdermal 17β-E2 with cyclic progestin — DRUG
    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 — DRUG
    2 mg of oral 17β-E2 pills daily, with 200 mg micronized progesterone given for 12 days of every month
  • transdermal EE+LNG — DRUG
    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).

Study Details

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

Key Dates

Start date
Oct 1, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: transdermal 17β-E2 with cyclic progestin
  • Experimental: oral 17β-E2 with cyclic progestin
  • Experimental: transdermal EE+LNG

Primary Outcome Measure

Areal BMD at the spine, hip and femoral neck as well as spine trabecular bone score from DXA [ Time Frame: Baseline and post-treatment (12 months) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Madhusmita Misra
[email protected]
434-924-9141
University of Virginia Medical CenterCharlottesvilleVirginia22903
Madhusmita Misra, MD, MPH
[email protected]
434-924-9141
[email protected]
Madhusmita Misra, MD, MPH (PRINCIPAL_INVESTIGATOR)
Christine Burt Solorzano, MD (SUB_INVESTIGATOR)

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By research site
University of Virginia· Charlottesville, VAUniversity of Virginia Medical Center· Charlottesville, VA

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