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:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT03018106
Eligibility Criteria:
Inclusion Criteria:
* Interested in resuming or continuing sexual activity
* Greater than 12 months since last menstrual cycle or prior bilateral oophorectomy
* Dyspareunia as a vulvovaginal atrophy symptom
* Normal mammogram within 12 months prior to entry into the study
Exclusion Criteria:
* History or suspicion of breast carcinoma
* History of hormone-dependent tumor
* Genital bleeding of unknown cause
* Ongoing vaginal infection
* History of cerebrovascular accident (CVA), myocardial infarction (MI) or heart disease
* Uncontrolled hypertension (HTN) over 160/100
* Serious disease or chronic condition that may prevent completion of study
* Body Mass Index (BMI) over 40
* Hypercoagulable state, or currently on anticoagulant therapy
* Use of any exogenous sex hormone within three months from study entry, or during the study
* Pelvic surgery within the last 12 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT03018106
Study Brief:
Protocol Section:
NCT03018106