Phase 2 N=11 Treatment

Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa

Anorexia Nervosa · Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT02475265 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA) — 2.0 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: estradiol 0.045 mg/levonorgestrel 0.015mg (Drug)
Age: Adult · 25+ yrs
Sex: Female
Sponsor: Massachusetts General Hospital
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA)	2.0	—

Summary

Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength. This study will investigate whether the use of transdermal estrogen can improve bone mineral density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa when used for 6 months.

Eligibility Criteria

Inclusion Criteria

Female; ages 25-50 years
Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) psychiatric criteria for AN, including 3 times the upper limit of normal
Fasting serum triglyceride level > 150 mg/dL
Pregnant or breastfeeding
Active substance abuse

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02475265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.