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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT04255160
Eligibility Criteria:
Inclusion Criteria:
* Peri-menopausal women between 40-58 years of age with variable cycles as defined by increase in cycle length of greater than 7 days within ten consecutive cycles, or amenorrhea for more than 2 months, but less than 12 months.
Exclusion Criteria:
* Women who are pregnant, planning on becoming pregnant, or are breast feeding;
* Women who have a history of cardiovascular disease, blood clots (e.g, pulmonary embolism or deep vein thrombosis), stroke, cancer, or liver disease;
* Women who have a body mass index less than 18 or greater than 35kg/m2;
* Women who use tobacco products;
* Women who's blood pressure is greater than 140/90 mmHg, have been diagnosed by a physician with hypertension or are taking medication for high blood pressure;
* Women who have a neurological disease, or diabetes;
* Women who have had a hysterectomy or have used hormones (birth control or hormone replacement) within the past 3 months;
* Women who have a latex allergy.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
58 Years
Study:
NCT04255160
Study Brief:
Protocol Section:
NCT04255160