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Taking people in United StatesPhase 2

Transdermal Estrogen in Women With Anorexia Nervosa

Key facts

Who runs it
Pouneh K. Fazeli, MD
Where
Pittsburgh, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
66 people, planned
Started
28 Aug 2020
Expected to end
31 Dec 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Transdermal estrogen
  • Placebos
Record updated
18 May 2026

Who can take part

Age
19 years to 45 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency (eGFR < 60)
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 19 and 45 years old?

Where in United States

  • University of Pittsburgh School of MedicinePittsburgh, United StatesContact: Pouneh K Fazeli, MDTaking people

About the trial

What the trial wants to find out

Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.

The 2 groups in the trial

  • Transdermal estrogen/progesteroneTreatment being tested

    Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) patch applied weekly for 18 months

    Treatment: Transdermal estrogen

  • PlaceboPlacebo, for comparison

    Placebo patch applied weekly for 18 months

    Treatment: Placebos

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Transdermal Estrogen for the Treatment of Bone Loss in Women With Anorexia Nervosa
Fit questions
Built from NCT03875378, who can take part
Record updated
18 May 2026