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

MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study.

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena)

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• India
  • Multiple Locations, India

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study subjects will be enrolled from multiple sites like women's hospitals, tertiary care institutes, Family planning clinics and gynaecological consulting centres.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; BAY 86-5028; Levonorgestrel- Intra Uterine System	Drug: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena); Levonorgestrel 52 mg intrauterine system with release rate of upto 20 mcg/day, Intrauterine insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Cumulative discontinuation rate for pregnancy		12 months
Cumulative discontinuation rate for other medical reasons		12 months
Cumulative discontinuation rate for non-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	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	12 months
Incidence rate of drug-related adverse events		12 months

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2015
• Primary Completion (Actual): November 28, 2018
• Study Completion (Actual): September 21, 2023

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimated): October 11, 2013

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: 16199; MA1210IN (Other Identifier: company internal)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.