Trial Condition(s):

Contraception

MIRENA for contraception In InDian subjects user continuAtion and Satisfaction study: MIDAS Study (MIDAS)

Bayer Identifier:

16199

ClinicalTrials.gov Identifier:

NCT01961375

EudraCT Number:

Not Available

Recruitment Complete

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.

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.

Trial Summary

Enrollment Goal
600
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, India

Status
Active, not recruiting
 

Trial Design