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

Overview

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.

Full Title of Study: “MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 28, 2018

Interventions

  • Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)
    • Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion

Arms, Groups and Cohorts

  • Group 1
    • BAY 86-5028; Levonorgestrel- Intra Uterine System

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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