Acceptability of Long-term Progestin-only Contraception in Europe

Completed

• Conditions: Contraception
• Interventions: Drug: Levonorgestrel IUS (Mirena, BAY86-5028); Drug: Implanon (Etonogestrel)

• Registration Number: NCT00931827
• Lead Sponsor: Bayer

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-06-30
• Study First Submitted QC: 2009-06-30
• Study First Posted: 2009-07-02
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-22
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 436

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Levonorgestrel IUS (Mirena, BAY86-5028)	-
Group 2	Implanon (Etonogestrel)	-

Primary Outcome Measures

Name	Time	Method
Continuation rate	At 24 months

Secondary Outcome Measures

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