Study on the Self-Administered Use of a Specialized Kit for the Management of Sexual Pain Associated With Endometriosis

NCT07683468 · ctgov recruiting

Enrollment: 100
Start: 2026-05-29
Completion: 2027-06-01
Last updated: 2026-07-06
Has results: False
Countries: France

Conditions

Endometriosis

Tagged with

endometriosis

Interventions

Specialized kit DEVICE
The kit used in the study contains: 1. The Endo-Sexo Guide: A 258-page book that compiles and analyzes possible responses to the SAQ. It explains in detail the mechanisms of sexual pain and offers personalized solutions to alleviate it (Guerrier-Benoit 2024) 2. The Endo Doute app: It allows women to keep a journal tracking pain (frequency and intensity), the frequency of sexual intercourse, and the tools used to relieve pain (including those provided in the kit). It also allows users to export their data to share with the healthcare professionals involved. 3. A set of practical tools for managing sexual pain on a daily basis, including an endo-vaginal TENS device to treat dyspareunia, penis rings to limit deep penetration, hyaluronic acid suppositories, CBD (cannabinoid) lubricant gel, sublingual CBD oil to reduce stress, as well as two dietary supplements.

Eligibility criteria

Inclusion Criteria: * Women aged 18 to 45 * Sexually active within the past 3 months * Confirmed diagnosis of endometriosis * Pain during sexual intercourse, as reported by the patient * Patients enrolled in or covered by the French social security system. * Patients who have been informed and have provided their free, informed, and written consent (no later than the day of enrollment and prior to any examination required for the study). Exclusion Criteria: * Patients participating in another interventional clinical trial for endometriosis. * Pregnant, breastfeeding, or laboring women * Patients who do not speak French or are unable to provide informed consent for the study * Patients with an allergy to any component of the study kit * Individuals who do not have a touchscreen mobile phone compatible with the Endo Doute app. * Participants whose physical and/or psychological health is severely impaired, which, in the investigator's opinion, may affect the participant's compliance with the study. * Participants currently in the exclusion period of another ongoing study at the time of enrollment. * Protected participants: adults under guardianship, conservatorship, or other legal protection; or individuals deprived of their liberty by judicial or administrative order.

License: public-domain-us · commercial use OK · attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine