Transdermal Estrogen in Women With Anorexia Nervosa
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Anorexia Nervosa
In brief
Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.
Key facts
- Study ID
- NCT03875378
- Run by
- Pouneh K. Fazeli, MD
- People needed
- 66
- Starts
- 2020-08-28
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-05-18
Who can join
Age: 19 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- 19-45 years of age
- DSM-5 psychiatric criteria for anorexia nervosa
- <85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
- Amenorrhea
- T-score of < -1.0 at spine or hip
You may not qualify if…
- Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency (eGFR < 60)
- Personal history of venous or arterial clot
- History of stroke or myocardial infarction
- History of hypercoagulable disorder
- Personal history or history of a first-degree relative with breast cancer
- History of hereditary angioedema
- Any medication known to affect bone metabolism, including systemic glucocorticoids within three months of the baseline visit, depot medroxyprogesterone within 6 months of the baseline visit, oral bisphosphonates within one year of the baseline visit or IV bisphosphonates within three years of the baseline visit
- Bone fracture within the prior 12 months
- Serum potassium < 3.0 meq/L, serum ALT > 3 times the upper limit of normal or Hemoglobin < 10 g/dL
- Fasting serum triglyceride level > 150 mg/dL
- Pregnant or breastfeeding (or desiring pregnancy within the next 18 months)
- Active substance abuse
- Elevated PTH level
- 25-OH vitamin D level < 20 ng/mL
- Low phosphorus level
Where it is running
- University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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