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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT03385603
Eligibility Criteria:
Inclusion Criteria:
* Females with sexual pain \>= 6 months
* Appropriate to use vaginal dilators
* The ability to read English and understand the informed consent form and screening questions
* The ability and willingness to follow all requirements of the study including following all directions and completion of daily pain reports
* Signed informed consent
* Are sexually active (have had intercourse at least twice in the last 30 days)
* Pain-related fear of intercourse greater than 50 on the numerical fear rating scale
Exclusion Criteria:
* Physical, psychological and medical issues, encountered during routine care that are felt insufficient for trial participation (physician discretion), such as poor mental status or neurological deficit limiting participation physically or cognitively (Mini-mental state exam less than 20).
* Women with sexual pain who are not sexually active (have not had intercourse at least twice in the last 30 days)
* Participants who use narcotic pain medication
* Participants diagnosed with a major depressive disorder
* Participants who exhibit signs and symptoms of infection, malignancy, or other conditions identified by a member of the study team that may be contraindications to the use of dilators
* Unable to readily access computer with Internet for reporting on daily fear levels and dilator size
* Pain-related fear of intercourse less than 50 on the numerical fear rating scale
* Women who are pregnant
* Participants who report a history of sexual abuse or trauma.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03385603
Study Brief:
Protocol Section:
NCT03385603