Acceptability of Long-term Progestin-only Contraception in Europe

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

436 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Contraception

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Levonorgestrel IUS (Mirena, BAY86-5028)

Intervention Type DRUG

Patients under daily life treatment receiving Mirena according to local drug information.

Group 2

Implanon (Etonogestrel)

Intervention Type DRUG

Patients under daily life treatment receiving Implanon according to local drug information.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levonorgestrel IUS (Mirena, BAY86-5028)

Patients under daily life treatment receiving Mirena according to local drug information.

Intervention Type DRUG

Implanon (Etonogestrel)

Patients under daily life treatment receiving Implanon according to local drug information.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Many Locations, , France

Site Status

Many Locations, , Ireland

Site Status

Many Locations, , Slovakia

Site Status

Many Locations, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France Ireland Slovakia United Kingdom