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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-30

Study Completion Date

2023-09-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

BAY 86-5028; Levonorgestrel- Intra Uterine System

Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)

Intervention Type DRUG

Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion

Interventions

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Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)

Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No