NCT02614781

Completed

Efficacy of Mifepristone - Prostaglandin Analogue Combinatio...

Nordic Pharma SAS Source

Compare

Other study identifiers

Sponsor study identifier

RYMMA

Study Type

observational

Actual enrollment (reported)

892

Locations

1 country

Sites

1

Timeline

Study Start

November 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2016

Actual (reported)

Study Completion

May 2016

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 892 participants
Study completion date: May 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2015
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 20, 2015
Actual (reported)
First Posted
November 25, 2015
Actual (reported)
Primary Completion
May 2016
Actual (reported)
Study Completion
May 2016
Actual (reported)

Last Updated: July 11, 2016
Status Verified: July 2016
Last Update Submitted: July 6, 2016

Conditions

Medical Termination of Pregnancy

Outcome Measures

Primary Outcomes (1)

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 (5)

Success rate of the protocol Mifegyne and misoprostol per os.
at the follow up at 2-3 weeks after the inclusion
rate of ongoing pregnancy by term.
at the follow up at 2-3 weeks after the inclusion
rate of patients requiring any additional procedures by term.
at the follow up at 2-3 weeks after the inclusion
Number of medical abortion using misoprostol
at the follow up at 2-3 weeks after the inclusion
Evaluation by patients of pain using a 5 level verbal rating scale
at the follow up at 2-3 weeks after the inclusion

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

women asking for medical abortion

You may qualify if:

Adult women (≥ 18 years old) with confirmed intra-uterine pregnancy consulting for medical termination of pregnancy

Sponsors & Collaborators

Nordic Pharma SAS
Industrylead

Study Sites (1)

Hôpital de la Conception

Marseille, 13385, France

Study Officials

Hélène HERMAN-DEMARS, MD
NORDIC PHARMA
STUDY DIRECTOR

Enrollment

892 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 25, 2015

Study Start

November 2015

Date type not reported

This date has not been verified as actual or estimated.

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

May 2016

Actual (reported)

Study Completion

May 2016

Actual (reported)

Last Updated

July 11, 2016

Record last verified: 2016-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02614781
Data provider: ClinicalTrials.gov
Source updated: 2016-07-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:36 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations