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 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT00712595
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic uterine leiomyomata
* Reproductive age or premenopausal
* Accepting the use of non hormonal contraception
* Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone
* Agreeing to have ultrasound examinations in every follow-up or evaluation visit
* Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination.
Exclusion Criteria:
* Pregnancy or desire to become pregnant
* Breastfeeding
* Hormonal contraception or any hormonal therapy received in the last three months
* Signs or symptoms of pelvic inflammatory disease
* Adnexal masses
* Abnormal or unexplained vaginal bleeding
* Suspected or diagnosed malignant neoplastic disease
* Signs or symptoms of mental illness
* Adrenal disease
* Sickle cell anemia
* Hepatic disease
* Renal disease
* Coagulopathy
* Any other severe or important disease
* Any contraindication to receiving antiprogestins
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00712595
Study Brief:
Protocol Section:
NCT00712595