Acceptability of Long-term Progestin-only Contraception in Europe

Study Overview
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Brief Summary
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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.

Official Title
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Acceptability of Long-term Progestin-only Contraception in Europe

Conditions
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Contraception

Intervention / Treatment
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* Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
* Drug: Implanon (Etonogestrel)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Levonorgestrel IUS (Mirena, BAY86-5028)<br>* Patients under daily life treatment receiving Mirena according to local drug information.<br>|
| Group 2<br> | Drug: Implanon (Etonogestrel)<br>* Patients under daily life treatment receiving Implanon according to local drug information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuation rate |  | At 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception