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.
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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

Madhusmita Misra, MD, MPH

434-924-9141

madhusmita.misra@uvahealth.org

CONTACT

Sara Braslow, BA

434-982-4234

EVZ3BW@uvahealth.edu

CONTACT