EndometriosisDYSEXTRIOSENCT01402791
Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples
An observational study of Endometriosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The primary objective of this study is to evaluate the presence/absence and description of persistent sexual troubles following surgical treatment for endometriosis for women, and their partners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endometriosis
- What is being tested?
- Questionnaires
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Couples for whom the women have been surgically treated for deep endometriosis at the Nîmes University Hospital
Who may be able to join
- The patient (and her partner) must have given his/her informed and signed consent
- The patient (and her partner) must be insured or beneficiary of a health insurance plan
- Couples for whom the woman has formerly undergone surgical treatment for endometriosis, and for the partner agrees to respond to questionnaires for this study
Who cannot join
- The patient (or her partner) is participating in another study
- The patient (or her partner) is in an exclusion period determined by a previous study
- The patient (or her partner) is under judicial protection, under tutorship or curatorship
- The patient (or her partner) refuses to sign the consent
- It is impossible to correctly inform the patient (or her partner)
- The patient is pregnant
- The patient is breastfeeding
- The patient was surgically treated for endometriosis, but was single.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to evaluate the presence/absence and description of persistent sexual troubles following surgical treatment for endometriosis for women, and their partners.
- Conditions
- Endometriosis
- Being tested
- Questionnaires
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
All included couples (women and their partners) are required to fill out several questionnaires: 1. Questionnaire for women; 2. Self-questionnaire for women; 3. SFQ for women; 4. Questionnaire for men; 5. Self-questionnaire for men; 6. IIEF for men.
| Study group | Role | What they receive |
|---|---|---|
| The study population | All patients included according to state inclusion and exclusion criteria. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score for the SFQ questionnaire
Score for the SFQ questionnaire; varies from 0 to 5.
Measured: Day 1
Score for the IIEF questionnaire
Score for the IIEF questionnaire; varies from 0 to 75.
Measured: Day 1
Secondary outcomes (3)
Scores for each sub-domain of the SFQ questionnaire
Scores for each sub-domain of the SFQ questionnaire; varies from 0 to 5.
Measured: Day 1
Scores for each sub-domain of the IIEF questionnaire
Scores for each sub-domain of the IIEF questionnaire; varies from 0 to 30.
Measured: Day 1
Sexual treatment request (yes/no)
Did the patients request treatment/help for sexual problems? yes/no
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Droupy, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402791
- Sponsor's protocol ID
- LOCAL/2011/SD-05
- Other IDs
- 2011-A00564-37
- Acronym
- DYSEXTRIOSE
- Status last verified
- Mar 2015
- First submitted
- 25 Jul 2011
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples
- ClinicalTrials.gov ID
- NCT01402791
- Acronym / sponsor ID
- DYSEXTRIOSE / LOCAL/2011/SD-05
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Jul 2011 (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.
The primary objective of this study is to evaluate the presence/absence and description of persistent sexual troubles following surgical treatment for endometriosis for women, and their partners.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Other: QuestionnairesAll patients included according to state inclusion and exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Couples for whom the women have been surgically treated for deep endometriosis at the Nîmes University Hospital
Key inclusion criteria (3 listed)
- The patient (and her partner) must have given his/her informed and signed consent
- The patient (and her partner) must be insured or beneficiary of a health insurance plan
- Couples for whom the woman has formerly undergone surgical treatment for endometriosis, and for the partner agrees to respond to questionnaires for this study
Key exclusion criteria (8 listed)
- The patient (or her partner) is participating in another study
- The patient (or her partner) is in an exclusion period determined by a previous study
- The patient (or her partner) is under judicial protection, under tutorship or curatorship
- The patient (or her partner) refuses to sign the consent
- It is impossible to correctly inform the patient (or her partner)
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 |
|---|---|---|
| QuestionnairesAll included couples (women and their partners) are required to fill out several questionnaires: 1. Questionnaire for women; 2. Self-questionnaire for women; 3. SFQ for women; 4. Questionnaire for men; 5. Self-questionnaire for men; 6. IIEF for men. | Other | The study population |
Primary outcome
Score for the SFQ questionnaire
Time frame: Day 1
Score for the SFQ questionnaire; varies from 0 to 5.
Score for the IIEF questionnaire
Time frame: Day 1
Score for the IIEF questionnaire; varies from 0 to 75.
3 secondary outcomes
Scores for each sub-domain of the SFQ questionnaire
Time frame: Day 1
Scores for each sub-domain of the IIEF questionnaire
Time frame: Day 1
Sexual treatment request (yes/no)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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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.
Stéphane Droupy, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Centre Hospitalier Universitaire de Nīmes 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 3 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: finished, as of the sponsor's last update on 26 Mar 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score for the SFQ questionnaire (time frame: Day 1). 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 26 Mar 2015.