Status:
RECRUITING
Transdermal Estrogen in Women With Anorexia Nervosa
Lead Sponsor:
Pouneh K. Fazeli, MD
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Anorexia Nervosa
Eligibility:
FEMALE
19-45 years
Phase:
PHASE2
Brief Summary
Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.
Detailed Description
Anorexia nervosa is a prevalent psychiatric with a lifetime prevalence of up to 2.2%. Among the many medical co-morbidities associated with anorexia nervosa, the most common is significant bone loss, ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03875378
Start Date
August 28 2020
End Date
December 31 2028
Last Update
August 7 2025
Active Locations (1)
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1
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213