Transdermal Estrogen in Women With Anorexia Nervosa
Transdermal Estrogen for the Treatment of Bone Loss in Women With Anorexia Nervosa
2 other identifiers
interventional
66
1 country
1
Brief Summary
Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2020
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2019
CompletedFirst Posted
Study publicly available on registry
March 14, 2019
CompletedStudy Start
First participant enrolled
August 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
August 7, 2025
August 1, 2025
8 years
March 11, 2019
August 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in bone mineral density at 18 months
Change in lumbar spine bone mineral density at 18 months
Baseline, 18 months
Secondary Outcomes (5)
Change in bone mineral density at hip at 18 months
Baseline, 18 months
Change in bone mineral density at femoral neck at 18 months
Baseline, 18 months
Change in parameters of bone microarchitecture at 18 months
Baseline, 18 months
Change in estimated bone strength at 18 months
Baseline, 18 months
Change in vertebral fractures at 18 months
Baseline, 18 months
Study Arms (2)
Transdermal estrogen/progesterone
EXPERIMENTALTransdermal estradiol (0.045mg)/levonorgestrel (0.015mg) patch applied weekly for 18 months
Placebo
PLACEBO COMPARATORPlacebo patch applied weekly for 18 months
Interventions
Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) weekly patch
Eligibility Criteria
You may qualify if:
- Female
- 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
- OH vitamin D level \< 20 ng/mL
- Low phosphorus level
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pouneh Fazeli, MD
University of Pittsburgh
Central Study Contacts
Shari Reynolds
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
March 11, 2019
First Posted
March 14, 2019
Study Start
August 28, 2020
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
August 7, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 12 months after publication and no pre-specified end date.
The final dataset will include self-reported demographic and behavioral data from interviews with the subjects, laboratory data from blood specimens provided and radiologic images of subjects with anorexia nervosa. Because anorexia nervosa is a psychiatric disease and we will be collecting identifying information, even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that the information disclosed by the subjects should be protected in the most stringent way possible in order to prevent possible identification of subjects. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.