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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT03185169
Eligibility Criteria:
Inclusion Criteria:
1. Female
2. Postmenopausal women (defined as last menstrual period \> 1 year ago or 6 months ago with FSH \>40) who have been diagnosed with breast cancer including in situ carcinoma (DCIS, LCIS)
3. Have self-identified GSM signs and objective symptoms on baseline screening
4. Patients already using Replens™ or coconut oil will have a two week washout period prior to starting study treatment.
5. Medical History review and Pelvic Exam by a board certified gynecologist for baseline assessment OR medical records review by a board certified gynecologist or delegated study staff to confirm diagnosis of GSM. If GSM is to be verified by medical record review, the sub-investigator will make the final determination of eligibility.
Exclusion Criteria:
1. Use of any estrogen containing product within 4 weeks prior to screening
2. Endometrial hyperplasia, endometrial cancer, or other gynecologic malignancy
3. Patients with non GSM related signs and symptoms as verified by a board certified gynecologist will be excluded.
4. Any concurrent illness or disorder that, per the opinion of the investigator, would preclude the patient from meeting the study requirements.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT03185169
Study Brief:
Protocol Section:
NCT03185169