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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT00474851
Eligibility Criteria:
Inclusion Criteria:
* Age 13-22 years, at least two years post-menarche
* Body mass index (BMI, kg/m2) between 18 -30 kg/m2
* Surgical diagnosis of endometriosis
* Clinical decision to treat with a GnRH agonist, leuprolide depot (Lupron Depot®; TAP Pharmaceuticals, Inc.) 11.25 mg intra-muscular every 3 months
Exclusion Criteria:
* Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, renal disease, or diabetes mellitus
* Markedly impaired liver function or liver failure
* Personal history of thromboembolic event (such as deep venous thrombosis)
* Medication use known to affect bone metabolism:
* Glucocorticoid therapy (including inhaled steroids) or anticonvulsants used in the last 6 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
13 Years
Maximum Age:
22 Years
Study:
NCT00474851
Study Brief:
Protocol Section:
NCT00474851