Management of Women With Superficial Dyspareunia | NCT06142851

Studies
Management of Women With Superficial Dyspareunia

NCT06142851

Sponsor

Université de Reims Champagne-Ardenne

Status

Unknown status

Last Update Posted

Nov 22, 2023Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Superficial Dyspareunia

Interventions

Data collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Feb 1, 2024Estimated

Completion Date

May 1, 2024Estimated

First Submitted Date

Nov 15, 2023

First Submission Date that Met QC Criteria

Nov 15, 2023

First Posted Date

Nov 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2023

Last Update Posted Date

Nov 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: Data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	data collection	Women with superficial dyspareunia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
medical history	Question to the woman about possible pain during sexual intercourses by an health professional (yes or no)	Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Minors
Protected by law (guardianship, curatorship, safeguarding of justice)
Refusing to participate in the study

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women with superficial dyspareunia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Barbe Coralie, DR	Contact	0326913665	+33	coralie.barbe@univ-reims.fr
CURRS CURRS	Contact	0326918822	+33	currs@univ-reims.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ufr Medecine Urca		Reims		51100	France
Université de Reims Champagne Ardenne

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided