Skip to main content
OpenTrials
Completed

NCT Number: NCT01961375

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contraception

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Multiple Locations, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Percentage continuation rate of LNG IUS at end of observation period.

    Time frame: 12 months

  2. Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied

    Time frame: 12 months

Secondary outcomes

  1. Cumulative discontinuation rate for pregnancy

    Time frame: 12 months

  2. Cumulative discontinuation rate for other medical reasons

    Time frame: 12 months

  3. Cumulative discontinuation rate for non-medical reasons

    Time frame: 12 months

  4. Mean percentage of women with amenorrhea

    Time frame: 12 months

  5. Mean percent of women with spotting, inter-menstrual bleeding

    Time frame: 12 months

  6. Distribution of contraceptive usage patterns

    Time frame: 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

  7. Incidence rate of drug-related adverse events

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: MIDAS

Important dates

Study start
2015
Primary completion
2018
Study completion
2023
First posted
Oct 11, 2013
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.