Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acceptability of Long-term Progestin-only Contraception in Europe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00931827
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : December 24, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date June 30, 2009
First Posted Date July 2, 2009
Last Update Posted Date December 24, 2013
Study Start Date January 2008
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2012)
Continuation rate [ Time Frame: At 24 months ]
Original Primary Outcome Measures
 (submitted: June 30, 2009)
Continuation rate [ Time Frame: During 12 months ]
Change History Complete list of historical versions of study NCT00931827 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 21, 2012)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: June 30, 2009)
  • Continuation rate [ Time Frame: During 12 months ]
  • Bleeding intensity, dysmenorrhea, and user satisfaction [ Time Frame: Initial and after 3, 6, 12 and 24 months ]
  • Cumulative discontinuation rate for unintended pregnancy [ Time Frame: During 24 months ]
  • Cumulative discontinuation rate for bleeding problems [ Time Frame: During 24 months ]
  • Cumulative discontinuation rate for other medical reasons [ Time Frame: During 24 months ]
  • Cumulative discontinuation rate for non-medical reasons [ Time Frame: During 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acceptability of Long-term Progestin-only Contraception in Europe
Official Title Acceptability of Long-term Progestin-only Contraception in Europe
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women aged 20-35 years switching from short-acting hormonal contraception
Condition Contraception
Intervention
  • 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.
Study Groups/Cohorts
  • Group 1
    Intervention: Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
  • Group 2
    Intervention: Drug: Implanon (Etonogestrel)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 21, 2012)
436
Original Estimated Enrollment
 (submitted: June 30, 2009)
800
Actual Study Completion Date November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovakia,   France,   Ireland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00931827
Other Study ID Numbers 14688
MA0801 ( Other Identifier: company internal )
14239 ( Other Identifier: company internal )
14177 ( Other Identifier: company internal )
14176 ( Other Identifier: company internal )
14016 ( Other Identifier: company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2013