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EndometriosisKIT-ENDO-SEXONCT07683468

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

A study testing Specialized kit in people with Endometriosis, run by Elsan at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometriosis
What is being tested?
Specialized kit
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteFrance
Study dates
29 May 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Clinique de l'Estrée

    Stains, 93240

    Magalie Benoit, PhD, 1 49 71 71 71 ext. +33, dr.magalie.benoit@gmail.com

    Recruiting

Other trials in France

About this study

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

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.

Read more

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.

Read the 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.

Conditions
Endometriosis
Being tested
Specialized kit
Keywords
sexual health, endometriosis, pain
Medical subject headings
Endometriosis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Specialized kitDevice

    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.
Study groups in NCT07683468
Study groupRoleWhat they receive
No specialized kitNo interventionPatients will not receive the specialized kit and will continue their usual routine.
With specialized kitExperimentalPatients will be given the specialized kit and will be free to use the different elements as they wish.
Receives: Device: Specialized kit

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to 3 months afterwards

Secondary outcomes (6)
  1. Sexual quality of life after 3 months of specialized kit's use

    To 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.

    Measured: From reception of the kit to 3 months afterwards

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

    Frequency of use of the kit's various components during the first 3 months of use (based on information entered into the EndoDoute app)

    Measured: From reception of the kit to 3 months afterwards

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

    To 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.

    Measured: From enrollement to 3 months afterwards

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

    Assess 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.

    Measured: From enrollement to 6 months afterwards

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

    Assess 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.

    Measured: From enrollement to 3 months afterwards

  6. Incidence of treatment-emergent adverse events

    Incidence of treatment-emergent adverse events between the group using the kit and the group not using the kit at 3 months.

    Measured: From enrollment to 3 months afterwards

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start29 May 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07683468
Sponsor's protocol ID
KIT-ENDO-SEXO
Other IDs
2025-A02206-43
Acronym
KIT-ENDO-SEXO
Status last verified
Jul 2026
First submitted
25 Jun 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Specialized kit in people with Endometriosis, run by Elsan at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sexual quality of life at 3 months between kit and no kit (time frame: From enrollment to 3 months afterwards). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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