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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT05350618
Eligibility Criteria:
Inclusion Criteria:
* No pain during sexual intercourse (for the healthy women)
* Moderate to severe pain (≥ 5/10) during sexual intercourse for at least 3 months (for women with provoked vestibulodynia)
* Moderate to severe pain (≥ 5/10) at least 90% of the time when engaging in or attempting sexual intercourse for at least 3 months (for women with provoked vestibulodynia)
Exclusion Criteria:
* Current or past pregnancy
* Urogynecological condition (e.g., pelvic organ prolapse stage ≥ 3, urinary leakage, current urinary/vaginal infection or in the last 3 months)
* Other causes of vulvo-vaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
* Post-menopausal state
* Previous vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, pelvic organ prolapse surgery)
* Physiotherapy within the last 9 months
* More than 3 physiotherapy treatment within last year
* Medication that could influence pain perception (e.g., analgesic, antidepressant)
* Other medical conditions that could interfere with the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05350618
Study Brief:
Protocol Section:
NCT05350618