Efficacy of Mifepristone - Prostaglandin Analogue Combina... | NCT02614781

Studies
Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea

NCT02614781

Sponsor

Nordic Pharma SAS

Status

Completed

Last Update Posted

Jul 11, 2016Estimated

Enrollment

892Actual

Phase

Not provided

Conditions

Medical Termination of Pregnancy

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

Jul 2016

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

Nov 2015

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Nov 20, 2015

First Submission Date that Met QC Criteria

Nov 23, 2015

First Posted Date

Nov 25, 2015Estimated

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

Jul 6, 2016

Last Update Posted Date

Jul 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study is a non-interventional prospective, multicenter, longitudinal study conducted in France, among a representative sample of public and/or private birth control centers.

The aim of the study is to assess, in real-life settings, the success rate of the protocol Mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or beyond 7 weeks of amenorrhea.

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

892Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
success rate of the protocol Mifegyne and prostaglandin analogue	The success rate will be defined as complete abortion without surgical procedure	At the follow-up at 2-3 weeks after inclusion

Secondary Outcomes

Measure	Description	Time Frame
Success rate of the protocol Mifegyne and misoprostol per os.	The success rate will be defined as complete abortion without surgical procedure	at the follow up at 2-3 weeks after the inclusion
rate of ongoing pregnancy by term.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult women (≥ 18 years old) with confirmed intra-uterine pregnancy consulting for medical termination of pregnancy
Patients for whom the physician decides to use a Mifegyne 600 mg and prostaglandin analogue combination for medical abortion
Patients agreeing to participate in the study after having been informed orally by the physician and given the information sheet
Informed patients accepting the computer processing of their medical data and their right of access and correction

Exclusion Criteria:

Patients with known hypersensitivity to mifepristone
Patients with known hypersensitivity to prostaglandin analogues (misoprostol or gemeprost).
Patients with severe and progressive disease
Patients with ectopic pregnancy

Accepts Healthy Volunteers

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 asking for medical abortion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hélène HERMAN-DEMARS, MD	NORDIC PHARMA	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital de la Conception		Marseille		13385	France