DyspareuniaNCT02484196
Dyspareunia in Women With Endometriosis: Impact of Surgery on Sexual Health
An observational study of Dyspareunia and Endometriosis, run by University of Cagliari.
Trial summary
Endometriosis is a disease that affects different areas of individual functioning, including the area of sexual life. Women with endometriosis have an impairment of desire and sexual arousal, orgasmic capacity reducted because of the pain and deep dyspareunia. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspareunia, Endometriosis
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Women, and their parteners, affected by endometriosis with dyspareunia, referred to the Obstetrics and Gynecological Department of the University Hospital for the treatment of endometriosis
Who may be able to join
- Women affected by endometriosis with dyspareunia;
- Women in waiting list for surgery
Who cannot join
- Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological)
- Psychiatric diseases
- Refusal or inability to sign the informed consent
- Pregnancy
- Previous gynecological surgery
- End of couple relationship
About this study
Endometriosis is a disease that affects different areas of individual functioning, including the area of sexual life. Women with endometriosis have an impairment of desire and sexual arousal, orgasmic capacity reducted because of the pain and deep dyspareunia. The aim of the study is to evaluate the effectiveness of surgery on dyspareunia in women with endometriosis, taking into account other variables involved in determining dyspareunia: the quality of the couple relationship, anxiety and depression, body image, coping strategies and resilience.
- Conditions
- Dyspareunia, Endometriosis
- Being tested
- Questionnaires
- Medical subject headings
- Dyspareunia, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Couples | Women, with their partners, referred to the Obstetrics and Gynecological Department of the University Hospital for surgical treatment of endometriosis. Receives: Behavioral: Questionnaires | |
| Women | Women referred to the Obstetrics and Gynecological Department of the University Hospital for surgical treatment of endometriosis. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of sexual life
Measured: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4weeks; Change from baseline were evalueted 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start1 Jun 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspareuniaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484196
- Sponsor's protocol ID
- ENDODISP14
- Status last verified
- Jan 2021
- First submitted
- 23 Jun 2015
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyspareunia in Women With Endometriosis: Impact of Surgery on Sexual Health
- ClinicalTrials.gov ID
- NCT02484196
- Acronym / sponsor ID
- ENDODISP14
- Conditions
- Dyspareunia, Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Jun 2015 (estimated)
- 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.
Endometriosis is a disease that affects different areas of individual functioning, including the area of sexual life. Women with endometriosis have an impairment of desire and sexual arousal, orgasmic capacity reducted because of the pain and deep dyspareunia. The aim of the study is to evaluate the effectiveness of surgery on dyspareunia in women with endometriosis, taking into account other variables involved in determining dyspareunia: the quality of the couple relationship, anxiety and depression, body image, coping strategies and resilience.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couples | – | Behavioral: QuestionnairesWomen, with their partners, referred to the Obstetrics and Gynecological Department of the University Hospital for surgical treatment of endometriosis. |
| Women | – | Behavioral: QuestionnairesWomen referred to the Obstetrics and Gynecological Department of the University Hospital for surgical treatment of endometriosis. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women, and their parteners, affected by endometriosis with dyspareunia, referred to the Obstetrics and Gynecological Department of the University Hospital for the treatment of endometriosis
Key inclusion criteria (2 listed)
- Women affected by endometriosis with dyspareunia;
- Women in waiting list for surgery
Key exclusion criteria (6 listed)
- Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological)
- Psychiatric diseases
- Refusal or inability to sign the informed consent
- Pregnancy
- Previous gynecological surgery
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 |
|---|---|---|
| QuestionnairesQuestionnaires | Behavioural | Couples, Women |
Primary outcome
Quality of sexual life
Time frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4weeks; Change from baseline were evalueted 2 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspareunia and Endometriosis, run by University of Cagliari.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 sexual life (time frame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of endometriosis up to 4weeks; Change from baseline were evalueted 2 months after surgery). 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 2 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.