Acceptability of Long-term Progestin-only Contraception in Europe

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2011

Interventions

  • 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

  • Group 1
  • Group 2

Clinical Trial Outcome Measures

Primary Measures

  • Continuation rate
    • Time Frame: At 24 months

Secondary Measures

  • Continuation rate
    • Time Frame: At 12 months
  • Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient)
    • Time Frame: 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
  • Incidence of Adverse Events, Serious Adverse Events
    • Time Frame: During 24 months
  • The return to fertility of women discontinuing the method for wish for pregnancy
    • Time Frame: 12 months after discontinuation

Participating in This Clinical Trial

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: Female

Minimum Age: 20 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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