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Mirena Efficiency and Tolerability During the First Year of Use

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: NCT00696202
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE June 10, 2008
First Posted Date  ICMJE June 12, 2008
Last Update Posted Date December 31, 2014
Study Start Date  ICMJE September 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2008)
Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena [ Time Frame: within 12 months after randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00696202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2008)
General safety assessment [ Time Frame: within 12 months after randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mirena Efficiency and Tolerability During the First Year of Use
Official Title  ICMJE A Multicentre, Open Label, Uncontrolled Study of the Tolerance, Acceptability and Contraceptive Efficacy of Mirena 52 mg®, an Intra-uterine Levonorgestrel Device, During the First Year After Insertion Post-partum
Brief Summary In this trial the efficacy and safety of Mirena was investigated during the first year of use
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Medicated Intrauterine Devices
  • Contraception
Intervention  ICMJE Drug: Mirena (BAY86-5028)
Intrauterine levonorgestrel containing device (market product)
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Mirena (BAY86-5028)
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2014)
199
Original Actual Enrollment  ICMJE
 (submitted: June 11, 2008)
150
Actual Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition).

Exclusion Criteria:

  • Standard exclusion criteria for use of intrauterine hormone devices
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00696202
Other Study ID Numbers  ICMJE 91295
307702
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

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