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:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT05129332
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years or older
* English or Spanish speaking
* Patients currently or previously treated for:
* Gynecologic cancer (surgery, chemotherapy, adjuvant vaginal brachytherapy)
* Breast cancer (chemotherapy, aromatase inhibitors, or selective estrogen receptor modulators; surgical menopause)
* Current desire for penetrative sexual activity
* Endorsement of at least one of the following in the last 6 months:
* Dyspareunia during penetrative sexual activity
* Reported sensation of penetrative object (partner's penis, sex toy) not fitting in the vagina
* Avoidance of penetrative sexual activity due to fear of pain
* Physically able to insert a vaginal dilator by themselves
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with prior primary or upfront pelvic radiation
* Patients with whole pelvic radiation at any time
* Patients with a history of chronic pelvic pain
* Patients with vulvodynia as noted on baseline pelvic exam with \> 5/10 pain score during an external exam with a cotton swab
* Patients with prior vaginal dilator use for any indication
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05129332
Study Brief:
Protocol Section:
NCT05129332