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

Completed

• Conditions: Contraception
• Interventions: Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)

• Registration Number: NCT01961375
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-11
• Study Start: 2015-10-30
• Primary Completion: 2018-11-28
• Study Completion: 2023-09-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

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.

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Exclusion Criteria

• Exclusion criteria must be read in conjunction with the local product information.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)	BAY 86-5028; Levonorgestrel- Intra Uterine System

Primary Outcome Measures

Name	Time	Method
Percentage continuation rate of LNG IUS at end of observation period.	12 months
Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied	12 months

Secondary Outcome Measures

Name	Time	Method
Cumulative discontinuation rate for non-medical reasons	12 months
Cumulative discontinuation rate for pregnancy	12 months
Cumulative discontinuation rate for other medical reasons	12 months
Mean percentage of women with amenorrhea	12 months
Mean percent of women with spotting, inter-menstrual bleeding	12 months
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
Incidence rate of drug-related adverse events	12 months