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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT02460302
Eligibility Criteria:
Inclusion criteria:
1. Age greater than or equal to 45, unless the patient has had a bilateral oophorectomy
2. Amenorrheic for greater than one year and/or FSH \> 40IU/mL
3. Women who have had a bilateral oophorectomy will be eligible at any age
4. Patients must have greater than or equal to two urogenital atrophy symptoms:
* vaginal dryness
* vaginal irritation
* vaginal soreness
* dyspareunia
Exclusion criteria:
1. Age less than 45
2. Systemic or local hormone replacement therapy use within three months of entry into study
3. Known or suspected history of breast cancer
4. Hormone dependent tumor
5. Genital bleeding of unknown cause
6. Current vaginal infection requiring treatment
7. Known allergy to test constituents
8. Serious disease or chronic condition that could interfere with compliance
9. Active thrombophlebitis, or history of a hormone-associated thrombophlebitis
10. Kidney disease
11. Liver dysfunction or disease
12. High LDL levels
Women who have used systemic or local hormone replacement therapy will be ineligible for participation in the study. If these women wish to participate, they must undergo a washout period. This would be as follows:
* eight weeks for oral estrogen and/or progestin therapy
* four weeks for transdermal or local vaginal hormone therapies
* eight weeks for progestin containing intrauterine system
Participants who are completing a washout period must complete the study questionnaire following the washout period.
Women will not be allowed to continue or commence use of non-hormonal therapies, including vaginal moisturizers, while they are in the study, However, we will allow the use of vaginal lubricants for sexual intercourse. Their use will be recorded on the patient questionnaire.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT02460302
Study Brief:
Protocol Section:
NCT02460302