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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT01358760
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women (non-hysterectomized or hysterectomized)
* Women between 40 and 75 years of age
* Willing to participate in the study and sign an informed consent
* Women who have self-identified symptom(s) of vaginal atrophy
* For non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study
Exclusion Criteria:
* Undiagnosed abnormal genital bleeding
* Hypertension equal to or above 140/90 mm Hg
* The administration of any investigational drug within 30 days of screening visit
* Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT01358760
Study Brief:
Protocol Section:
NCT01358760