Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction (Mirabel)

October 15, 2015 updated by: Bayer

Prospective Multicentre Non-interventional Comparative Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction

This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2348

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females who plan long-term contraception and meet criteria of inclusion and exclusion.

Description

Inclusion Criteria:

  • Women 20-40 years old
  • Parity ≥ 1 child
  • Requesting long-term contraception
  • Written informed consent.

Exclusion Criteria:

  • in accordance with the current leaflet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Levonorgestrel (Mirena, BAY86-5028)
intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel
Group 2
Device: Copper IUD
Copper device, inserted intrauterine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
User satisfaction of the contraception method with Mirena or Copper IUD
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD
Time Frame: up to 12 months
up to 12 months
Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)
Time Frame: up to 12 months
up to 12 months
Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)
Time Frame: up to 12 months
up to 12 months
Relationship between different parameters and women preferences in choosing Mirena or Cooper IUD as their contraceptive method ( demographic parameters, age group, residence, reproductive history and plans, etc.) using patients questionnaire
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (ESTIMATE)

May 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15508
  • MA1010RU (OTHER: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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