Acceptability of Long-term Progestin-only Contraception in Europe

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

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.

Intervention(s) in this Clinical Trial

• Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
  • Patients under daily life treatment receiving Mirena according to local drug information.
• Drug: Implanon (Etonogestrel)
  • Patients under daily life treatment receiving Implanon according to local drug information.

Arms, Groups and Cohorts in this Clinical Trial

• : Group 1
• : Group 2

Primary Measures

• Continuation rate
  • Time Frame: During 24 months
    Safety Issue?: No

Secondary Measures

• Continuation rate
  • Time Frame: During 12 months
    Safety Issue?: No
• Bleeding intensity, dysmenorrhea, and user satisfaction
  • Time Frame: Initial and after 3, 6, 12 and 24 months
    Safety Issue?: No
• Cumulative discontinuation rate for unintended pregnancy
  • Time Frame: During 24 months
    Safety Issue?: No
• Cumulative discontinuation rate for bleeding problems
  • Time Frame: During 24 months
    Safety Issue?: No
• Cumulative discontinuation rate for other medical reasons
  • Time Frame: During 24 months
    Safety Issue?: No
• Cumulative discontinuation rate for non-medical reasons
  • Time Frame: During 24 months
    Safety Issue?: No
• Incidence of Adverse Events, Serious Adverse Events
  • Time Frame: During 24 months
    Safety Issue?: Yes
• The return to fertility of women discontinuing the method for wish for pregnancy
  • Time Frame: 12 months after discontinuation
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931827

Study ID Number: 14688

ClinicalTrials.gov Identifier: NCT00931827

Health Authority: France: French Data Protection Authority

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