Superficial DyspareuniadyspareunieNCT06142851
Management of Women With Superficial Dyspareunia
An observational study of Superficial Dyspareunia, run by Université de Reims Champagne-Ardenne at 2 sites in France.
Trial summary
Superficial dyspareunia are persistent or recurrent pains during an attempt at sexual intercourse or during effective penetration. They affect between 3 to 18% of women and are a source of physical and psychological suffering. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Superficial Dyspareunia
- What is being tested?
- Data collection
- How many people
- 2,000 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2023to 1 May 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with superficial dyspareunia
Who may be able to join
- Aged 18 or over
- Superficial dyspareunia, i.e.:
- Having already had several painful vaginal penetrative sex
- Having pain at the intromission (at the beginning of the vagina and at the level of the vulva) and/or at the beginning of penetration (by a penis, fingers, sextoys)
- Having persistent and/or recurrent pain (appearing in a manner regular)
- Agreeing to participate in the study
Who cannot join
- Minors
- Protected by law (guardianship, curatorship, safeguarding of justice)
- Refusing to participate in the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Ufr Medecine Urca
Reims, 51100
Université de Reims Champagne Ardenne
Reims, 51100
About this study
Superficial dyspareunia are persistent or recurrent pains during an attempt at sexual intercourse or during effective penetration.
They affect between 3 to 18% of women and are a source of physical and psychological suffering.
Some health professionals (gynecologists, general practitioners, midwives) are confronted daily with these complaints.
The approach of sexuality remains a complex subject even within the medical field. As a result, communication between women and health professionals can be difficult, leading to delayed diagnosis or inadequate management.
Read the detailed description
The main objective is to describe the management of superficial dyspareunia by health professionals.
- Conditions
- Superficial Dyspareunia
- Being tested
- Data collection
- Keywords
- superficial dyspareunia, management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
data collection
| Study group | Role | What they receive |
|---|---|---|
| Women with superficial dyspareunia | Adult women, having sexual activity with or without vaginal penetration, suffering from superficial dyspareunia, whether or not managed by health professionals. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
medical history
Question to the woman about possible pain during sexual intercourses by an health professional (yes or no)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142851
- Sponsor's protocol ID
- 2023_RIPH_017_PEC-dyspareunie
- Acronym
- dyspareunie
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Women With Superficial Dyspareunia
- ClinicalTrials.gov ID
- NCT06142851
- Acronym / sponsor ID
- dyspareunie / 2023_RIPH_017_PEC-dyspareunie
- Conditions
- Superficial Dyspareunia
- Keywords
- superficial dyspareunia, management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 22 Nov 2023 (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.
Superficial dyspareunia are persistent or recurrent pains during an attempt at sexual intercourse or during effective penetration.
They affect between 3 to 18% of women and are a source of physical and psychological suffering.
Some health professionals (gynecologists, general practitioners, midwives) are confronted daily with these complaints.
The approach of sexuality remains a complex subject even within the medical field. As a result, communication between women and health professionals can be difficult, leading to delayed diagnosis or inadequate management.
Detailed description
The main objective is to describe the management of superficial dyspareunia by health professionals.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with superficial dyspareunia | – | Other: Data collectionAdult women, having sexual activity with or without vaginal penetration, suffering from superficial dyspareunia, whether or not managed by health professionals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with superficial dyspareunia
Key inclusion criteria (6 listed)
- Aged 18 or over
- Superficial dyspareunia, i.e.:
- Agreeing to participate in the study
Key exclusion criteria (3 listed)
- Minors
- Protected by law (guardianship, curatorship, safeguarding of justice)
- Refusing to participate in the study
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 |
|---|---|---|
| Data collectiondata collection | Other | Women with superficial dyspareunia |
Primary outcome
medical history
Time frame: Day 0
Question to the woman about possible pain during sexual intercourses by an health professional (yes or no)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Superficial Dyspareunia
Active, not recruiting
Physiotherapeutic Approach to Superficial and Deep Dyspareunia in Women With Chronic Pelvic Pain: Comparison Between In-person and Telehealth Care.
Surface and Deep Dyspareunia
Recruiting
Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
Provoked Vestibulodynia
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Dyspareunia, run by Université de Reims Champagne-Ardenne at 2 sites 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 3 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 22 Nov 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbe Coralie, DR (0326913665 ext. +33, coralie.barbe@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medical history (time frame: Day 0). 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 22 Nov 2023.