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:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 12:55 AM
NCT ID:
NCT00320567
Eligibility Criteria:
Inclusion Criteria:
* Patients must have a monthly period
* health status consistent with anorexia nervosa
* meet the modified DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) guideline for anorexia nervosa
* must discontinue the following prior to Baseline visit: hormonal contraceptives for 3 months
* hormonal intrauterine devices (IUDs) for 1 month
* NORPLANT for 3 months
* DepoProvera and other depot hormone injections, for 6 months
* Lupron, Lupron Depot 3.75 mg and 7.5 mg, Synarel, Zoladex, Cetrotide for 3 months
* Lupron Depot 11.25 mg, 15 mg, 22.5 mg, 30 mg for 6 months
* non-smoker or smoking \<= 15 cigarettes per day
* must agree to use reliable non-hormonal alternate method of birth control during the study
Exclusion Criteria:
* History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy including but not limited to the following - active or history of deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor which developed during the use of oral contraceptives or estrogen-containing products, known or suspected carcinoma of any body system, diabetes mellitus with vascular involvement
* recent history of alcohol or substance abuse
* patients with primary amenorrhea (abnormal suppression or absence of menstruation) who in the opinion of the physician, are not appropriate candidates for hormonal therapy (eg, have not grown to an acceptable adult height)
* subjects who are suicidal
* patients who have received any experimental drug and/or used any experimental device within 30 days before the start of the study.
Healthy Volunteers:
False
Sex:
FEMALE
Maximum Age:
17 Years
Study:
NCT00320567
Study Brief:
Protocol Section:
NCT00320567