Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT03740204
Eligibility Criteria:
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 excessive exercise 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 \>15 years 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 14-18 year olds and a body mass index \<25 kg/m2 for adults
Exclusion criteria:
* Suicidal ideation where outpatient treatment is determined unsafe by study clinician
* Other causes of oligo-amenorrhea, unless a study clinician determines that missed menstrual 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 to three weekly blood samples for estradiol of if estradiol levels are determined to be too 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 could interfere with study participation or safety or put the subject at any unnecessary risk
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
14 Years
Maximum Age:
35 Years
Study:
NCT03740204
Study Brief:
Protocol Section:
NCT03740204