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MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study: MIDAS Study (MIDAS)

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ClinicalTrials.gov Identifier: NCT01961375
Recruitment Status : Active, not recruiting
First Posted : October 11, 2013
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date October 10, 2013
First Posted Date October 11, 2013
Last Update Posted Date November 5, 2019
Actual Study Start Date October 30, 2015
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2015)
  • Percentage continuation rate of LNG IUS at end of observation period. [ Time Frame: 12 months ]
  • Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied [ Time Frame: 12 months ]
Original Primary Outcome Measures
 (submitted: October 10, 2013)
  • Percentage continuation rate of LNG IUS at end of observation period [ Time Frame: 12 months ]
  • Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT01961375 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 10, 2013)
  • Cumulative discontinuation rate for pregnancy [ Time Frame: 12 months ]
  • Cumulative discontinuation rate for other medical reasons [ Time Frame: 12 months ]
  • Cumulative discontinuation rate for non-medical reasons [ Time Frame: 12 months ]
  • Mean percentage of women with amenorrhea [ Time Frame: 12 months ]
  • Mean percent of women with spotting, inter-menstrual bleeding [ Time Frame: 12 months ]
  • Distribution of contraceptive usage patterns [ Time Frame: 12 months ]
    contraceptive usage patterns included:birth-spacing, long term contraception, postpartum contraception, post-abortion contraception, switch from other method, contraception for other medical reasons like heart disease, etc
  • Incidence rate of drug-related adverse events [ Time Frame: 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study: MIDAS Study
Official Title MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study.
Brief Summary The study is designed as non interventional to observe the continuation rate and the patient satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system) inserted for contraception over the period of 12 months under real life condition in India.The study will begin after the study approval by ethics committee.All Indian women aged between 18-49 years who are initiating LNG IUS therapy for contraception will be included in study after taking the informed consent.Patients will be observed for upto 12 months.The study involves general examination of patients, collection of data like medical history, previous contraceptive use,concomitant medication etc.The study is planned to enroll 600 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.
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 Probability Sample
Study Population The study subjects will be enrolled from multiple sites like women's hospitals, tertiary care institutes, Family planning clinics and gynaecological consulting centres.
Condition Contraception
Intervention Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)
Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion
Study Groups/Cohorts Group 1
BAY 86-5028; Levonorgestrel- Intra Uterine System
Intervention: Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)
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 Active, not recruiting
Actual Enrollment
 (submitted: October 10, 2013)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 29, 2019
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subject aged between 18-49 years who are initiating LNG IUS therapy for contraception.
  • Subject willing to provide informed consent and comply with study procedure.

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT01961375
Other Study ID Numbers 16199
MA1210IN ( 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 November 2019