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:
NCT05342402
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of provoked vestibulodynia according to a standardized gynaecologic exam
2. Moderate to severe pain (≥5/10) located in the vulvar vestibule for at least 90% of vaginal penetrations or attempted vaginal penetrations or activities with pressure on the vagina for at least 3 months
Exclusion Criteria:
1. Other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
2. Prior vulvo-vaginal surgery or radiotherapy
3. Post-menopausal status
4. Participant refusal to not use other treatments for the provoked vestibulodynia during the entire study (until 3 months post-treatment);
5. Other urogynecological condition (e.g. pelvic organs prolapse ≥3, current urinary/vaginal infection or in the last 3 months)
6. Prior use of Somatosensory Rehabilitation Program or Educational Pain Management Program
7. Current or past pregnancy in the last year;
8. Changes of medication that could influence pain perception (e.g. analgesic, antidepressant) in the last 3 months
9. Major psychological condition (e.g. depressive symptoms, anxiety) which can present a security issue for the participant
10. Other medical conditions that could interfere with the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05342402
Study Brief:
Protocol Section:
NCT05342402