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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT02497560
Eligibility Criteria:
Inclusion Criteria:
* Age group between 45 and 65 at the time of informed consent.
* Physician diagnosis of menopause.
* History of substantial hot flashes \> 4 episodes /day for last 2 weeks.
* Being post-menopausal with an intact uterus.
* Subject has provided signed and dated written informed consent before admission to the study.
Exclusion Criteria:
* Concurrent hot flash therapies (prescription medications including hormone replacement therapies, gabapentin or over the counter supplements), vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products for 30 days before screening visit.
* Women currently or previously on anticoagulants, Vitamin K antagonists like warfarin in the past 3 months, or expected to be on anticoagulants in the near future.
* Women involved in other clinical studies within the last 30 days.
* Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT02497560
Study Brief:
Protocol Section:
NCT02497560