Clincosm LogoSign in Get a demo

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

Sponsor
Bayer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01961375
Collaborator
(none)
600
Enrollment
1
Location
82
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)

Study Design

Study Type:
Observational
Actual Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study.
Actual Study Start Date :
Oct 30, 2015
Actual Primary Completion Date :
Nov 28, 2018
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Group 1

BAY 86-5028; Levonorgestrel- Intra Uterine System

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

Outcome Measures

Primary Outcome Measures

  1. Percentage continuation rate of LNG IUS at end of observation period. [12 months]

  2. Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied [12 months]

Secondary Outcome Measures

  1. Cumulative discontinuation rate for pregnancy [12 months]

  2. Cumulative discontinuation rate for other medical reasons [12 months]

  3. Cumulative discontinuation rate for non-medical reasons [12 months]

  4. Mean percentage of women with amenorrhea [12 months]

  5. Mean percent of women with spotting, inter-menstrual bleeding [12 months]

  6. Distribution of contraceptive usage patterns [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

  7. Incidence rate of drug-related adverse events [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Multiple Locations India

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT01961375
Other Study ID Numbers:
  • 16199
  • MA1210IN
First Posted:
Oct 11, 2013
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Levonorgestrel

Study Results

No Results Posted as of Aug 22, 2022