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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT01776203
Eligibility Criteria:
Inclusion Criteria:
1. Premenopausal women 18-50 years of age
2. Requiring gonadrotropin-releasing hormone agonist for any indication except ovulation induction
3. If there is abnormal uterine bleeding, such bleeding is not obviously related to structural defects such as polyps or submucous leiomyomas; subserosal and intramural myomas (International Federation of Gynecology and Obstetrics Classification 3-8 inclusive) are acceptable
Exclusion Criteria:
1. Currently pregnant
2. Recent used of gonadrotropin-releasing hormone agonist
1. 1 month depot formulation eg leuprolide acetate 3.75, within 90 days
2. 3 month depot formulation eg leuprolide acetate 11.25 within 180 days
3. Currently has an intrauterine contraceptive device
4. Currently on gonadal steroids (including birth control pills, rings, or implantable or injectable agents)
5. History of breast cancer
6. Currently undergoing ovulation induction
7. History of adverse reactions to gonadal steroids
8. Hemoglobin \<8 mg/dl as measured within 30 days of enrollment (Baseline hemoglobin is standard of care for patients initiating gonadrotropin-releasing hormone agonist therapy)
9. Weight above \>250 lbs
10. Has a known submucous leiomyoma ( International Federation of Gynecology and Obstetrics Class type 0, 1, 2)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01776203
Study Brief:
Protocol Section:
NCT01776203