Phase
Condition
Mood Disorders
Treatment
17-β estradiol transdermal patches with cyclic progesterone
Placebo patch and pill
Clinical Study ID
Ages 14-35 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Female
14-35 years
Bone age ≥13.5 years (applicable only for participants <16 years)
Clinically significant eating disorder characterized by restriction and/or excessiveexercise and high drive for thinness
Hypoestrogenemia: Oligo-amenorrhea defined as lack of menses for ≥3 months within a 6-month period of oligomenorrhea (cycle length ≥5 weeks) or absence of menses at >15years if premenarchal or low estradiol levels evaluated by the study physician
Low or normal weight defined by a body mass index that is <85th percentile for 14-18year olds and a body mass index <25 kg/m2 for adults
Exclusion
Exclusion criteria:
Suicidal ideation where outpatient treatment is determined unsafe by study clinician
Other causes of oligo-amenorrhea, unless a study clinician determines that missedmenstrual periods are more likely a consequence of restrictive eating
Medications that contain estrogen ± progesterone within the past 3 months
Levonorgestrel-releasing intrauterine device if subject is unable to provide two tothree weekly blood samples for estradiol of if estradiol levels are determined to betoo high by study doctor
Neurological or psychiatric disorders that may impact neural circuitry of interest
Lifetime history of seizure disorder or electroconvulsive therapy
Pregnancy/breastfeeding
Gastrointestinal tract surgery
Contraindications to estrogen use
Any other significant illness or condition that the investigator determines couldinterfere with study participation or safety or put the subject at any unnecessaryrisk
Study Design
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
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