Acceptability of Long-term Progestin-only Contraception in Europe

December 22, 2013 updated by: Bayer
The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

436

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 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged 20-35 years switching from short-acting hormonal contraception

Description

Inclusion Criteria:

  • Women aged 20-35 in good general health requesting contraception
  • Women who have used short-acting hormonal contraception (combined or progestogen-only pills, vaginal ring or contraceptive patch) for at least 3 cycles immediately before entering the study and opting to change to either Mirena or Implanon for contraception
  • Women who have given a written informed consent to participate in the study (if applicable)

Exclusion Criteria:

  • The contraindications and warnings of the respective Summary of Product Characteristics (Mirena or Implanon) must be followed. The decision to start Mirena or Implanon has to be made clearly before the decision to include patients in the study
  • Patients who are breast-feeding at time of inclusion for the study will also be excluded since breast-feeding affects the bleeding pattern

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
Patients under daily life treatment receiving Mirena according to local drug information.
Group 2
Drug: Implanon (Etonogestrel)
Patients under daily life treatment receiving Implanon according to local drug information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Continuation rate
Time Frame: At 24 months
At 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Continuation rate
Time Frame: At 12 months
At 12 months
Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient)
Time Frame: Initial and after 3, 6, 12 and 24 months
Initial and after 3, 6, 12 and 24 months
Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons
Time Frame: At 24 months
At 24 months
Incidence of Adverse Events, Serious Adverse Events
Time Frame: During 24 months
During 24 months
The return to fertility of women discontinuing the method for wish for pregnancy
Time Frame: 12 months after discontinuation
12 months after discontinuation

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

January 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 22, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14688
  • MA0801 (Other Identifier: company internal)
  • 14239 (Other Identifier: company internal)
  • 14177 (company internal)
  • 14176 (company internal)
  • 14016 (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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