EndometriosisNCT06810297
Effect of a Therapeutic Exercise and an Education Program on Sexual Function and Experience in People With Endometriosis
A study testing Therapeutic Exercise and Therapeutic exercise and sexual education in people with Endometriosis and Sexual Function, run by University of Valencia at 2 sites in Spain.
Trial summary
This is a randomized clinical trial that will be carried out in people with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic exercise combine with sexual education, and the control group (CG) who will receive the therapeutic exercise program. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Sexual Function, Sex Behavior
- What is being tested?
- Therapeutic Exercise and Therapeutic exercise and sexual education
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesSpain
- Study dates
- 18 Oct 2024to Nov 2028
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- People of legal age (over 18 years old)
- Not older than 50 years old
- Currently residing in Spain
- Spanish speakers
- With a medical diagnosis of endometriosis
- Without any other associated gynecological pathology
Who cannot join
- Minors
- People over 50 years old
- Those with cognitive limitations that prevent them from completing the different questionnaires used
- People who are involved in litigation processes
- People with gynecological pathologies other than endometriosis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Laura Fuentes Aparicio
Valencia, 46010
University of Valencia
Valencia, 46010
About this study
This is a randomized clinical trial that will be carried out in people with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic exercise combine with sexual education, and the control group (CG) who will receive the therapeutic exercise program.
The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after 4 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). Objective and subjective data of the participants will be evaluated. T1 will be assessed with a sociodemographic questionnaire and the FSFI and MSSCQ surveys. T2 and T3 will assess blood pressure, heart rate, variability of the autonomic system, the ability to dissociate the lumbopelvic movement from the thoracolumbar, measurement of the muscles of the transverse, internal and external obliques, the distance between the rectus abdominis and the pelvic floor, subjective perception of effort during exercise and subjective perception of orgasmic intensity.
- Conditions
- Endometriosis, Sexual Function, Sex Behavior
- Being tested
- Therapeutic Exercise, Therapeutic exercise and sexual education
- Keywords
- Endometriosis, Sexual Function, Sexual Experience
- Medical subject headings
- Endometriosis, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ExerciseProcedure or surgery
It will consist of an 8-week intervention divided into 2 weekly sessions, in which functional exercise will be combined with aerobic exercise. A progressive protocol will be carried out.The sessions will last approximately 60 minutes divided into a first aerobic part which will serve as a warm-up for the functional part, then a main part with approximately 6 exercises and, finally, a cool-down of 3 to 5 minutes with relaxation exercises and stretching.
Therapeutic exercise and sexual educationCombination product
The sexual education part will consist of a 4-week intervention divided into 1 session every two weeks in an online format, in which topics related to the pathology and self-knowledge will be addressed. The sessions will last approximately 60 minutes, divided into a first part of reception and welcome of the group (lasting approximately 5-10 minutes), then the main content will be divided differently in each session (the explicit content of each session will be detailed later) and will end with a farewell and closing of the online session (lasting approximately 5-10 minutes) together with the explanation of the homework.
In addition, they will also carry out the therapeutic exercise protocol.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Exercise | Active comparator | They will recive the therapeutic exercise program. Receives: Procedure: Therapeutic Exercise |
| Therapeutic exercise and sexual education | Experimental | They will receive ta combined program, which will combine therapeutic exercise with a sexual education classes. Receives: Combination Product: Therapeutic exercise and sexual education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life - Sexual Function
The Index of Female Sexual Function (IFSF) will be used. It is a multidimensional self-reported instrument for the evaluation of female sexual function.
The scores for the same domain are added together and multiplied by the factor that corresponds to each domain. The total score is obtained by adding the scores for the 6 domains. A score of 0 in any of the domains indicates a lack of sexual activity in the last month.The maximum total score will be 36 points and the minimum 2. The higher the score, the better the sexual function.
Measured: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
Quality of Life - Sexual self-concept
Multidimensional Scale of Sexual Concept (MSSCQ) will be used. It is a multidimensional self-reported instrument for the evaluation of sexual self- concept.
Each answer has a score of 0 to 4 points. The higher the score, the better the sexual assertiveness and sexual self-concept. There are a total of 16 questions. The maximum score is 64 points and the minimum is 0.
Measured: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
Secondary outcomes (3)
Quality of Life - Pleasure
Visual Analogue Scale (VAS) of pleasure will be used. Orgasmic intensity is reported through a Likert scale (0-10) and a chromatic gradation, which fluctuate from 0 (white), corresponding to the absence of orgasmic intensity, to 10 (deep red), corresponding to the highest level of orgasmic intensity.
Measured: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
Physical-Funcionality - Motor control
Determine motor control: clinical test of lumpopelvic and thoracolumbar dissociation will be used.
The clinical test assesses the ability to dissociate lumbopelvic movement from that of the thoracolumbar junction, and to evaluate the inter-rater reliability of the test in individuals with and without low back pain (LBP) when performed by experienced and novice therapists. A clinical scale was developed to characterise quality of performance of lumbopelvic motion with limited motion at the thoracolumbar junction. The patient is asked to flex the trunk to see if there is lumbopelvic dissociation.
Measured: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
Physical-Funcionality- Pelvic floor and abdominal ultrasound
The ultrasound will measure muscle tone. This tone will be assessed in different situations. Measurement of basal tone, tone at maximum contraction, tone at Valsalva and tone at cough.
Measured: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start18 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Fuentes Aparicio, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810297
- Sponsor's protocol ID
- SEX-ENDOMETRIO-UV
- Status last verified
- May 2026
- First submitted
- 14 Jan 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Therapeutic Exercise and an Education Program on Sexual Function and Experience in People With Endometriosis
- ClinicalTrials.gov ID
- NCT06810297
- Acronym / sponsor ID
- SEX-ENDOMETRIO-UV
- Conditions
- Endometriosis, Sexual Function, Sex Behavior
- Keywords
- Endometriosis, Sexual Function, Sexual Experience
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized clinical trial that will be carried out in people with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic exercise combine with sexual education, and the control group (CG) who will receive the therapeutic exercise program.
The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after 4 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). Objective and subjective data of the participants will be evaluated. T1 will be assessed with a sociodemographic questionnaire and the FSFI and MSSCQ surveys. T2 and T3 will assess blood pressure, heart rate, variability of the autonomic system, the ability to dissociate the lumbopelvic movement from the thoracolumbar, measurement of the muscles of the transverse, internal and external obliques, the distance between the rectus abdominis and the pelvic floor, subjective perception of effort during exercise and subjective perception of orgasmic intensity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Exercise | Active comparator | Procedure: Therapeutic ExerciseThey will recive the therapeutic exercise program. |
| Therapeutic exercise and sexual education | Experimental | Combination Product: Therapeutic exercise and sexual educationThey will receive ta combined program, which will combine therapeutic exercise with a sexual education classes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- People of legal age (over 18 years old)
- Not older than 50 years old
- Currently residing in Spain
- Spanish speakers
- With a medical diagnosis of endometriosis
Key exclusion criteria (5 listed)
- Minors
- People over 50 years old
- Those with cognitive limitations that prevent them from completing the different questionnaires used
- People who are involved in litigation processes
- People with gynecological pathologies other than endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic ExerciseIt will consist of an 8-week intervention divided into 2 weekly sessions, in which functional exercise will be combined with aerobic exercise. A progressive protocol will be carried out.The sessions will last approximately 60 minutes divided into a first aerobic part which will serve as a warm-up for the functional part, then a main part with approximately 6 exercises and, finally, a cool-down of 3 to 5 minutes with relaxation exercises and stretching. | Procedure or surgery | Therapeutic Exercise |
| Therapeutic exercise and sexual educationThe sexual education part will consist of a 4-week intervention divided into 1 session every two weeks in an online format, in which topics related to the pathology and self-knowledge will be addressed. The sessions will last approximately 60 minutes, divided into a first part of reception and welcome of the group (lasting approximately 5-10 minutes), then the main content will be divided differently in each session (the explicit content of each session will be detailed later) and will end with a farewell and closing of the online session (lasting approximately 5-10 minutes) together with the explanation of the homework. In addition, they will also carry out the therapeutic exercise protocol. | Combination product | Therapeutic exercise and sexual education |
Primary outcome
Quality of Life - Sexual Function
Time frame: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
The Index of Female Sexual Function (IFSF) will be used. It is a multidimensional self-reported instrument for the evaluation of female sexual function. The scores for the same domain are added together and multiplied by the factor that corresponds to each domain. The total score is obtained by adding the scores for the 6 domains. A score of 0 in any of the domains indicates a lack of sexual activity in the last month.The maximum total score will be 36 points and the minimum 2. The higher the score, the better the sexual function.
Quality of Life - Sexual self-concept
Time frame: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
Multidimensional Scale of Sexual Concept (MSSCQ) will be used. It is a multidimensional self-reported instrument for the evaluation of sexual self- concept. Each answer has a score of 0 to 4 points. The higher the score, the better the sexual assertiveness and sexual self-concept. There are a total of 16 questions. The maximum score is 64 points and the minimum is 0.
3 secondary outcomes
Quality of Life - Pleasure
Time frame: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
Physical-Funcionality - Motor control
Time frame: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
Physical-Funcionality- Pelvic floor and abdominal ultrasound
Time frame: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Exercise and Therapeutic exercise and sexual education in people with Endometriosis and Sexual Function, run by University of Valencia at 2 sites in Spain.
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 5 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: enrolling by invitation, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life - Sexual Function (time frame: Measurements will be taken prior to the intervention (week 0 of the program), after the intervention has ended (week 8 of the program) and one month after the intervention has ended (week 12 of the program).). The study lists 2 primary outcomes in all. 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 18 May 2026.