Acceptability of Long-term Progestin-only Contraception in Europe

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00931827
First received: June 30, 2009
Last updated: December 22, 2013
Last verified: December 2013

June 30, 2009
December 22, 2013
January 2008
November 2011   (final data collection date for primary outcome measure)
Continuation rate [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
Continuation rate [ Time Frame: During 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00931827 on ClinicalTrials.gov Archive Site
  • Continuation rate [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient) [ Time Frame: Initial and after 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events, Serious Adverse Events [ Time Frame: During 24 months ] [ Designated as safety issue: Yes ]
  • The return to fertility of women discontinuing the method for wish for pregnancy [ Time Frame: 12 months after discontinuation ] [ Designated as safety issue: No ]
  • Continuation rate [ Time Frame: During 12 months ] [ Designated as safety issue: No ]
  • Bleeding intensity, dysmenorrhea, and user satisfaction [ Time Frame: Initial and after 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Cumulative discontinuation rate for unintended pregnancy [ Time Frame: During 24 months ] [ Designated as safety issue: No ]
  • Cumulative discontinuation rate for bleeding problems [ Time Frame: During 24 months ] [ Designated as safety issue: No ]
  • Cumulative discontinuation rate for other medical reasons [ Time Frame: During 24 months ] [ Designated as safety issue: No ]
  • Cumulative discontinuation rate for non-medical reasons [ Time Frame: During 24 months ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events, Serious Adverse Events [ Time Frame: During 24 months ] [ Designated as safety issue: Yes ]
  • The return to fertility of women discontinuing the method for wish for pregnancy [ Time Frame: 12 months after discontinuation ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Acceptability of Long-term Progestin-only Contraception in Europe
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Women aged 20-35 years switching from short-acting hormonal contraception

Contraception
  • 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.
  • Group 1
    Intervention: Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
  • Group 2
    Intervention: Drug: Implanon (Etonogestrel)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
436
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Female
20 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Ireland,   Slovakia,   United Kingdom
 
NCT00931827
14688, MA0801, 14239, 14177, 14176, 14016
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP