Skip to content

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

Single-Center, Controlled, Randomized Study on the Self-Administered Use of a Specialized Kit for the Management of Sexual Pain Associated With Endometriosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07683468
Acronym
KIT-ENDO-SEXO
Enrollment
100
Registered
2026-07-06
Start date
2026-05-29
Completion date
2027-06-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

sexual health, endometriosis, pain

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. 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. 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-one containing palmitoylethanolamide (PEA) to combat inflammation and the other made from herbs to aid menstrual comfort. These tools will be used independently by patients, offering them personalized solutions to better understand and manage their pain on their own. Each patient will be able to choose whether or not to use the various components of the kit and how often to use them. Empowering patients to manage their own pain should improve their sexual quality of life and reduce the need for occasional or unscheduled medical care. This project represents the first initiative aimed at evaluating the impact of these tools on patients' autonomy in managing sexual pain related to endometriosis.

Detailed description

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. Female sexual dysfunction refers to the various reasons why a woman is unable to engage in sexual intercourse as she would like. To address this need, Magalie Benoit, PhD in Gynecological Sciences and Psychotherapist, has developed an innovative methodology as well as three specific tools designed to support women with endometriosis in managing their sexual pain. 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 SAQ focuses on sexual pleasure, discomfort related to sexual intercourse, and the frequency of intercourse compared to a usual level. It is designed to accurately capture changes in sexual pain among women with endometriosis, where pain is often the predominant factor affecting their sexuality. The SAQ measures various aspects related to sexual pain, such as: * The intensity of pain experienced during sexual activity. * The emotional and psychological impact of sexual pain. * The effects on sexual satisfaction and overall sexual activity. The SAQ consists of three sections: hormonal status, reasons for sexual inactivity, and sexual functioning. This last section calculates the SAQ score, which is the sum of 10 questions rated on a 4-point Likert scale (0=Not at all, 1=A little, 2=Moderately, 3=A lot). The total score ranges from 0 to 30; the higher the score, the better the sexual functioning. The results obtained through this questionnaire 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. The Endo-Sexo Guide: A 258-page book that compiles and analyzes the responses obtained via the SAQ. It explains in detail the mechanisms of sexual pain and offers personalized solutions to alleviate it. 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 endovaginal 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 support menstrual comfort. These tools will be used independently by patients, offering them personalized solutions to better understand and manage their pain on their own. Each patient will be able to choose whether or not to use the various components of the kit and how often to use them. Empowering patients to manage their own pain should improve their quality of sexual life and reduce the need for occasional or unscheduled medical care. This project represents the first initiative aimed at evaluating the impact of these tools on patients' ability to manage endometriosis-related sexual pain on their own.

Interventions

DEVICESpecialized kit

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.

Sponsors

Elsan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sexual quality of life at 3 months between kit and no kitFrom enrollment to 3 months afterwardsTo 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.

Secondary

MeasureTime frameDescription
Sexual quality of life after 3 months of specialized kit's useFrom reception of the kit to 3 months afterwardsTo assess whether use of the Endo-Sexo kit improves the sexual quality of life of patients with endometriosis by comparing data before and after 3 months of kit use across all study patients. Sexual quality of life will be assessed using the Sexual Activity Questionnaire (SAQ). The difference in the total score between the baseline level and the level at 3 months will be analyzed for all patients (Day 0 vs. Day 90 for Group 1 and Day 90 vs. Day 180 for Group 2). 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.
Evaluating the use of the Endo-Sexo kit over a 3 months periodFrom reception of the kit to 3 months afterwardsFrequency of use of the kit's various components during the first 3 months of use (based on information entered into the EndoDoute app)
Pelvic pain modulation by specialized kit's use over 3 monthsFrom enrollement to 3 months afterwardsTo measure changes in pelvic pain levels (based on data from the EndoDoute app) after 3 months of use by comparing patients who used the kit with those who did not.The difference in the numerical score (from 1 to 5) for pelvic pain between baseline and day 90 (based on information entered into the EndoDoute app) will be studied.
Long-term effect of the specialized kit on sexual quality of lifeFrom enrollement to 6 months afterwardsAssess the long-term effect of the kit (in Group 1 patients only, comparing Day 0, Day 90, and Day 180) Sexual quality of life will be assessed using the Sexual Activity Questionnaire (SAQ). The difference in the total score between baseline and the 3-month mark will be compared to the difference in the total score between baseline and the 6-month mark for patients in Group 1. 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.
Need for additional medical care with and without the use of the specialized kitFrom enrollement to 3 months afterwardsAssess the need for unplanned medical care after 3 months of use by comparing patients with and without the kit. The number of unplanned medical appointments related to endometriosis during the first 3 months of the study willl be compared between patients in Group 1 and Group 2.
Incidence of treatment-emergent adverse eventsFrom enrollment to 3 months afterwardsIncidence of treatment-emergent adverse events between the group using the kit and the group not using the kit at 3 months.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026