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

NCT07683468 | Recruiting

• 2 other identifiers: KIT-ENDO-SEXO2025-A02206-43
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a complex gynecological condition that affects approximately 10% of women of reproductive age, according to 2023 data from the World Health Organization. Endometriosis is often associated with debilitating pain, particularly during sexual intercourse (dyspareunia). This pain profoundly affects these patients' sexual health and, consequently, their quality of life, yet it remains frequently misunderstood and inadequately managed, partly due to a lack of information and appropriate tools. One of the key aspects of this study is the use of the Sexual Activity Questionnaire (SAQ), an internationally recognized assessment tool for measuring the impact of treatment on sexual functioning. The SAQ collects precise data on sexual activity (primarily frequency), the level of sexual pleasure, and the perceived pain potential experienced by patients during sexual activity, assessing not only the intensity of pain but also its influence on the emotional and relational aspects of intimate life. The SAQ has been validated to assess the impact of surgical treatments for endometriosis on sexual functioning. The results obtained through this questionnaire in routine clinical practice formed the basis for the tools developed by Dr. Magalie Benoit, providing an in-depth understanding of the different types of pain experienced by patients. The kit used in the study contains:

1. 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.
2. 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. 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-one containing palmitoylethanolamide (PEA) to combat inflammation and the other made from herbs to aid menstrual comfort.

Conditions

Endometriosis

Keywords

sexual health; endometriosis; pain

Outcome Measures

Primary Outcomes (1)

• Sexual quality of life at 3 months between kit and no kit

  To assess whether using the Endo-Sexo kit improves the quality of sexual life for patients with endometriosis after 3 months of use by comparing patients who use the kit with those who do not. Sexual quality of life will be assessed using the Sexual Activity Questionnaire (SAQ). The difference in total scores between baseline and day 90 will be compared between the two groups. Nine of the ten SAQ items are rated on a 4 point Likert scale from 0 (not at allà to 3 (very much), therefore the total score can go from 0 to 27, with the last item being the frequency of sexual relations. A high score on the pleasure subscale represents high pleasure, and a low score on the discomfort subscale represents low discomfort.

  From enrollment to 3 months afterwards

Secondary Outcomes (6)

• Sexual quality of life after 3 months of specialized kit's use

  From reception of the kit to 3 months afterwards

• Evaluating the use of the Endo-Sexo kit over a 3 months period

  From reception of the kit to 3 months afterwards

• Pelvic pain modulation by specialized kit's use over 3 months

  From enrollement to 3 months afterwards

• Long-term effect of the specialized kit on sexual quality of life

  From enrollement to 6 months afterwards

• Need for additional medical care with and without the use of the specialized kit

  From enrollement to 3 months afterwards

Study Arms (2)

No specialized kit

NO INTERVENTION

Patients will not receive the specialized kit and will continue their usual routine.

With specialized kit

EXPERIMENTAL

Patients will be given the specialized kit and will be free to use the different elements as they wish.

Device: Specialized kit

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.

With specialized kit

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Protected participants: adults under guardianship, conservatorship, or other legal protection; or individuals deprived of their liberty by judicial or administrative order.

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Clinique de l'Estrée

Stains, 93240, France

RECRUITING

MeSH Terms

Conditions

Endometriosis; Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: During the first phase the design is parallel with a comparison between two study groups (one with the specialized kit and one without), then all patients will be given the kit and followed for six months.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 6, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)