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

NCT01961375 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-10-13

No results posted yet for this study

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.

Conditions

  • Contraception

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-30
Primary Completion
2018-11-28
Completion
2023-09-21

Countries

  • India

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01961375 on ClinicalTrials.gov