Actively Recruiting
Transdermal Estrogen in Women With Anorexia Nervosa
Led by Pouneh K. Fazeli, MD · Updated on 2025-08-07
66
Participants Needed
1
Research Sites
435 weeks
Total Duration
On this page
Sponsors
P
Pouneh K. Fazeli, MD
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.
CONDITIONS
Official Title
Transdermal Estrogen in Women With Anorexia Nervosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age between 19 and 45 years
- Diagnosis of anorexia nervosa based on DSM-5 criteria
- Weight less than 85% of ideal body weight
- Amenorrhea (absence of menstrual periods)
- Bone density T-score less than -1.0 at the spine or hip
You will not qualify if you...
- Diseases affecting bone metabolism such as untreated thyroid problems, vitamin D deficiency, Cushing's syndrome, diabetes, or kidney problems
- History of blood clots
- History of stroke or heart attack
- Blood clotting disorders
- Personal or first-degree relative history of breast cancer
- History of hereditary angioedema
- Use of medications affecting bone metabolism recently or within specific time frames
- Bone fracture within the last 12 months
- Abnormal blood test results including low potassium, high liver enzymes, low hemoglobin, or high triglycerides
- Pregnant, breastfeeding, or planning pregnancy within 18 months
- Active substance abuse
- Elevated parathyroid hormone levels
- Very low vitamin D levels
- Low phosphorus levels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
P
Pouneh Fazeli, MD
CONTACT
S
Shari Reynolds
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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