Estrogen Therapy for Eating Disorders
Trial Summary
What is the purpose of this trial?
This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. Subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. Study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. Study procedures comprise behavioral, neuroimaging, and endocrine assessments.
Will I have to stop taking my current medications?
The trial requires that you have not taken medications containing estrogen or progesterone in the past 3 months. If you are using a levonorgestrel-releasing intrauterine device, you may need to provide blood samples or stop if estradiol levels are too high.
What data supports the effectiveness of the drug 17-β estradiol transdermal patches with cyclic progesterone for eating disorders?
Research shows that 17-β estradiol transdermal patches, like Climara, are effective in relieving symptoms related to menopause and may help protect against conditions like cardiovascular disease and osteoporosis. While this doesn't directly relate to eating disorders, it suggests the drug can effectively deliver hormones, which might be beneficial in managing symptoms related to hormonal imbalances.12345
Is estrogen therapy using transdermal patches generally safe for humans?
Research shows that transdermal estrogen patches, like Climara and Estraderm, are generally well tolerated in humans. They have been used safely for hormone replacement therapy, with minor side effects such as skin irritation and fluid retention, but no serious adverse effects have been reported.12467
How is the drug 17-β estradiol transdermal patches with cyclic progesterone unique for treating eating disorders?
Research Team
Madhusmita Misra, M.D., M.P.H.
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
This trial is for female adolescents and young adults aged 14-35 with low estrogen levels, an eating disorder characterized by extreme dietary restriction or excessive exercise, and a high drive for thinness. Participants must not be pregnant, breastfeeding, have used estrogen treatments recently, or have any health conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 17-β estradiol transdermal patches with cyclic progesterone (Hormone Therapy)
- Placebo patch and pill (Drug)
17-β estradiol transdermal patches with cyclic progesterone is already approved in Canada for the following indications:
- vasomotor symptoms of vulvar and vaginal atrophy in menopause
- hypoestrogenism
- prevention of postmenopausal osteoporosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor