check_circleStudy Completed

Contraception

Bayer Identifier:

14688

ClinicalTrials.gov Identifier:

NCT00931827

EudraCT Number:

Not Available

EU CT Number:

Not Available
Acceptability of long-term progestin-only contraception in Europe

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

20 - 35 Years

  • - 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)

  • - 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

Trial summary

Enrollment Goal
436
Trial Dates
January 2008 - November 2011
Phase
N/A
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, United Kingdom
Completed
Many Locations, France
Completed
Many Locations, Slovakia
Completed
Many Locations, Ireland

Primary Outcome

  • Continuation rate
    date_rangeTime Frame:
    At 24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

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

Trial design

Acceptability of long-term progestin-only contraception in Europe
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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