Perception of Female Hormonal Contraception by the Main P... | NCT05528731

Studies
Perception of Female Hormonal Contraception by the Main Prescribers

NCT05528731

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Dec 13, 2023Actual

Enrollment

385Actual

Phase

Not provided

Conditions

Female Hormonal Contraception

Interventions

Not provided

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2022Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Jan 31, 2023Actual

First Submitted Date

Sep 2, 2022

First Submission Date that Met QC Criteria

Sep 2, 2022

First Posted Date

Sep 6, 2022Actual

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

Dec 12, 2023

Last Update Posted Date

Dec 13, 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

The recommendations for contraception, after researching contraindications to certain methods, are to offer clear and honest information to allow the patient to make an informed choice, adapted to her lifestyle. The best contraception is the one chosen by the patient. The choice of contraception illustrates the difficulty of assessing the benefit-risk balance in the context of functional and preventive treatment.

Taking into account this imbalance between patient beliefs and medical advice is an essential step in improving the provision of gynecological care.

Detailed Description

Not provided

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

385Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Study of the perception of risks and management of adverse effects of hormonal contraception among prescribers		5 months after interviews with prescribers

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Any health care professional in general medicine, gynecology and midwifery
graduate or in progress
in practice (any practice modality in metropolitan France)
agreeing to participate in the survey by completing the questionnaire anonymously, after having read the information and non-objection notice attached to the questionnaire.

Exclusion criteria:

- Any other health profession

Inclusion criteria:

- Any health care professional in general medicine, gynecology and midwifery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any health care professional in general medicine, gynecology and midwifery, graduate or in progress in practice (any practice modality in metropolitan France)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Assistance Médicale à la Procréation - CHU de Strasbourg - France		Strasbourg		67091	France