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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT02693002
Eligibility Criteria:
Inclusion Criteria:
* 28 healthy recently postmenopausal women with last menstrual bleeding 12 months at study entry. Women with last menstrual bleeding within 12 months at study entry are those who are peri-menopausal and for whom the drug is FDA approved.
Exclusion Criteria:
* History of hysterectomy, oophorectomy or both
* History of heart disease including cardiac transplantation, heart failure, bypass surgery or percutaneous intervention, and valve disease defined as moderate or severe valve regurgitation or stenosis
* History of bone disease including non-traumatic vertebral fractures on radiography
* Uncontrolled chronic disease (including uncontrolled diabetes defined as a hemoglobin A1C \>8, uncontrolled hypertension defined as a systolic blood pressure \>160 mmHg, awaiting organ transplant)
* Previous or current cancer, excluding basal cell carcinoma
* Previous or current thromboembolic disease
* Previous intolerance of Hormone replacement therapy (HRT) or Oral contraception (OC)
* Current or previous use of HRT within the past 3 months
* Current or recent (\<12 months) substance abuse, including tobacco use
* No drug interactions with HRT
* No racial or ethnic groups will be excluded
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
55 Years
Study:
NCT02693002
Study Brief:
Protocol Section:
NCT02693002