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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT05692960
Eligibility Criteria:
Inclusion Criteria:
* History of breast cancer, stages I, II or III
* Completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 5 years prior to registration
* May use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study
* May use topical products (e.g., lidocaine) vaginally prior to penetrative vaginal sex
* Ability to read and write English
* Able to engage in sexual activity
* Currently has a sexual partner Responds "yes" to "Do you currently experience vaginal or vulvar dryness and/or pain with sexual activity?"
* Responds "yes" to at least one of the following questions:
1. "Have you experienced negative changes in your body image since being diagnosed or treated for cancer?" or
2. "Have you experienced negative changes in your sexual desire since being diagnosed or treated for cancer?"
Exclusion Criteria:
* Antidepressants are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change
* History of sexual abuse
* Psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history and/or patient self-report)
* Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed)
* Use of oral, transdermal or vaginal estrogen is not allowed while on study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05692960
Study Brief:
Protocol Section:
NCT05692960