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

Bayer

Status: Completed

Conditions: Contraception

Treatments: Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)

Study type: Observational

Funder types: Industry

Identifiers

NCT01961375

16199

MA1210IN (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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 design

600 participants in 1 patient group

Group 1

Description:

BAY 86-5028; Levonorgestrel- Intra Uterine System

Treatment:

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