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Role of Estrogen on Skeletal Outcomes in FHA

NCT07010146 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-17

No results posted yet for this study

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

Conditions

  • Bone Strength
  • Bone Density
  • FHA (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).

Sponsors & Collaborators

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

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Madhusmita Misra, MD, MPH · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2029-12-31
Completion
2030-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07010146 on ClinicalTrials.gov