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

Contraception Clinical Trial

— MIDAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961375
• Other study ID #: 16199
• Secondary ID: MA1210IN
• Status: Completed
• Start date: October 30, 2015
• Est. completion date: September 21, 2023

Study information

• Verified date: October 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 21, 2023
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage continuation rate of LNG IUS at end of observation period.		12 months
Primary	Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied		12 months
Secondary	Cumulative discontinuation rate for pregnancy		12 months
Secondary	Cumulative discontinuation rate for other medical reasons		12 months
Secondary	Cumulative discontinuation rate for non-medical reasons		12 months
Secondary	Mean percentage of women with amenorrhea		12 months
Secondary	Mean percent of women with spotting, inter-menstrual bleeding		12 months
Secondary	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
Secondary	Incidence rate of drug-related adverse events		12 months

External Links

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