Role of Estrogen on Skeletal Outcomes in FHA
Recruiting
Phase 2
Interventional Study
Bone Strength
Bone Density
FHA (Functional Hypothalamic Amenorrhea)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 14 – 30
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- University of Virginia · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Females, age 14-30 years, skeletally mature with bone age ≥ 14 years (only 2% of growth left)
* Women of reproductive age: use of an effective non-hormonal contraceptive method or a progestin releasing intrauterine device (no systemic skeletal effects) for study duration if se…
Contacts