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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT02477202
Eligibility Criteria:
Inclusion Criteria:
* Women between 35 and 50 years of age (inclusive)
* Women who will be scheduled to undergo an RRSO or RRs
* Women who will have at least one fallopian tube removed for risk-reducing reasons (with or without removal of ovar(ies))
* Women who are willing to have a Mirena® IUD inserted at least prior to risk-reducing surgery or who already have the Mirena® in place
* Women using non-hormonal forms of contraception (Note: If a copper IUD is being used, the IUD must be removed prior to or at time of Mirena insertion.)
Exclusion Criteria:
* Any medical contraindication to use of a Mirena® IUD, including:
* Pregnancy (a pregnancy test is required prior to study entry)
* Known uterine anomaly that distorts the shape of the uterine cavity
* Acute pelvic inflammatory disease
* Postpartum endometritis or endometrial infection
* Known or suspected uterine or cervical neoplasia
* Known history or suspected breast cancer or other progestin-sensitive cancer
* Uterine bleeding of unknown etiology.
* Untreated acute cervicitis, vaginitis, or other lower genital tract infections
* Acute liver disease or liver tumor (benign or malignant)
* Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months
* Positive pregnancy test
* Breastfeeding
* Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena® IUD
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
50 Years
Study:
NCT02477202
Study Brief:
Protocol Section:
NCT02477202