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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT05910294
Eligibility Criteria:
Inclusion Criteria:
* Women, 18 years of age or older
* Breast cancer patients with hormone receptor positive breast cancer , stage 0-III
* Premenopausal or perimenopausal women who have either been pregnant or had at least one menstrual period in the last 24 months or have/had an IUD in place
* Patients currently on or are being initiated on ovarian suppression
* Patients are asymptomatic for vaginal symptoms of estrogen deprivation (i.e. vaginal dryness, dyspareunia, or discomfort \[pain with intercourse or examination\]) and score a 3 or less on the VAS and VuAS
Exclusion Criteria:
* Postmenopausal women who have been without a period for ≥ 2 years
* Patients who score a 4 or above on the VAS and VuAS
* Patients already using VVA treatment (e.g. intravaginal estrogen, other non-hormonal moisturizer or suppository), unless discontinued with washout of 4 weeks
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05910294
Study Brief:
Protocol Section:
NCT05910294