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 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT01455350
Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe pain in at least 90% of sexual intercourses.
* Moderate to severe pain during the cotton-swab test at one of more vestibule regions (5/10 minimum pain evaluation on the verbal pain intensity scale).
* Pain limited to the vestibule during vaginal penetrations and during activities applying pressure on the vestibule.
* Provoked vestibulodynia lasting at least 6 months prior to the study and diagnosed by a standardised gynaecologic exam protocol by one of our collaborator.
Exclusion Criteria:
* Major psychiatric condition or pelvic pathology associated with a genital pain problem (e.g.: dyspareunia).
* Use of medication that could influence pain perception.
* Actual or past pregnancy.
* Vulvar or vaginal surgery
* Post-menopausal state
* Unwillingness to restrain from other treatments till the 6 months post-treatment evaluation.
* Urogynaecologic symptoms (urinary/anal incontinence, pelvic organs prolapsus, urinary/vaginal infection active or during the last 3 months).
* Incapacity to have sexual intercourse including vaginal penetration during the last 6 months.
* Physiotherapy treatments or lidocaine application prior to the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01455350
Study Brief:
Protocol Section:
NCT01455350