check_circleStudy Completed

Contraception

Bayer Identifier:

16199

ClinicalTrials.gov Identifier:

NCT01961375

EudraCT Number:

Not Available

EU CT Number:

Not Available
MIRENA for contraception In InDian subjects user continuAtion and Satisfaction study: MIDAS Study

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 49 Years
  • - 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 must be read in conjunction with the local product information.

Trial summary

Enrollment Goal
600
Trial Dates
October 2015 - September 2023
Phase
N/A
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many Locations, India

Primary Outcome

  • Percentage continuation rate of LNG IUS at end of observation period.
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Cumulative discontinuation rate for pregnancy
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Cumulative discontinuation rate for other medical reasons
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Cumulative discontinuation rate for non-medical reasons
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean percentage of women with amenorrhea
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean percent of women with spotting, inter-menstrual bleeding
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Distribution of contraceptive usage patterns
    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
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Incidence rate of drug-related adverse events
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

MIRENA for contraception In InDian subjects user continuAtion and Satisfaction study.
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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