Frontlight ResearchEarly access
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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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