MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Levonorgestrel- Intra Uterine System (BAY 86-5028_Mirena) (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact: Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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.
Clinical Details
Official title: MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Percentage continuation rate of LNG IUS at end of observation period.Percentage of Women with user satisfaction scoring somewhat satisfied to very satisfied
Secondary outcome: Cumulative discontinuation rate for pregnancyCumulative discontinuation rate for other medical reasons Cumulative discontinuation rate for non-medical reasons Mean percentage of women with amenorrhea Mean percent of women with spotting, inter-menstrual bleeding Distribution of contraceptive usage patterns Incidence rate of drug-related adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Many Locations, India; Not yet recruiting
Additional Information
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Starting date: September 2015
Last updated: August 3, 2015
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