Transdermal Estrogen for the Treatment of Bone Loss in Women With Anorexia Nervosa
Who is this study for? Adult female patients with Anorexia Nervosa
What treatments are being studied? Estrogen
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 45
Healthy Volunteers: f
View:
• 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
Locations
United States
Pennsylvania
University of Pittsburgh School of Medicine
RECRUITING
Pittsburgh
Contact Information
Primary
Pouneh Fazeli, MD
pkfazeli@pitt.edu
412-586-9700
Backup
Shari Reynolds
Time Frame
Start Date: 2020-08-28
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 66
Treatments
Experimental: Transdermal estrogen/progesterone
Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) patch applied weekly for 18 months
Placebo_comparator: Placebo
Placebo patch applied weekly for 18 months
Related Therapeutic Areas
Sponsors
Leads: Pouneh K. Fazeli, MD
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)