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Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice (MARILIA)

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ClinicalTrials.gov Identifier: NCT01833793
Recruitment Status : Completed
First Posted : April 17, 2013
Last Update Posted : September 14, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

March 13, 2013
April 17, 2013
September 14, 2015
February 2013
November 2014   (Final data collection date for primary outcome measure)
  • Proportion of Mirena users who have at least one period of Amenorrhea of at least three months [ Time Frame: 12 months ]
  • Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01833793 on ClinicalTrials.gov Archive Site
  • Proportion of Mirena users who have menstrual disorders [ Time Frame: 12 months ]
  • Proportion of Mirena users with menorrhagia [ Time Frame: 12 months ]
  • Cumulative rate of satisfaction in Mirena users [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice
Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion
MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Women who have been prescribed Mirena for contraception.
Female Contraception
Drug: Levonorgestrel IUD (Mirena, BAY86-5028)
Women who have been prescribed Mirena in contraception; followed up for 12 months
Group 1
Intervention: Drug: Levonorgestrel IUD (Mirena, BAY86-5028)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
500
May 2015
November 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 19-40 years at the time of Mirena IUD insertion
  • Using Mirena only for contraception indication
  • Never having used the product before
  • No heavy menstrual bleeding diagnosed
  • Have signed informed consent to participate in this study

Exclusion Criteria:

  • Nulliparous
  • Pregnancy
  • Mirena's contre-indication
  • Mirena for HMB
  • Abnormal bleeding pattern
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Algeria
 
 
NCT01833793
16314
MA1211DZ ( Other Identifier: Company internal )
Yes
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2015