Trial Condition(s):
Contraception
MIRENA for contraception In InDian subjects user continuAtion and Satisfaction study: MIDAS Study (MIDAS)
Bayer Identifier:
16199
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, India | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
MIRENA for contraception In InDian subjects user continuAtion and Satisfaction study.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Percentage continuation rate of LNG IUS at end of observation period.Timeframe: 12 months
- Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfiedTimeframe: 12 months
Secondary Outcome
- Cumulative discontinuation rate for pregnancyTimeframe: 12 months
- Cumulative discontinuation rate for other medical reasonsTimeframe: 12 months
- Cumulative discontinuation rate for non-medical reasonsTimeframe: 12 months
- Mean percentage of women with amenorrheaTimeframe: 12 months
- Mean percent of women with spotting, inter-menstrual bleedingTimeframe: 12 months
- Distribution of contraceptive usage patternscontraceptive 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, etcTimeframe: 12 months
- Incidence rate of drug-related adverse eventsTimeframe: 12 months
Additional Information
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