Trial Condition(s):
Female contraception
Descriptive, prospective, non-interventional study (NIS) to describe Mirena and Amenorrhea related acceptability in contraception indication in medical practice (MARILIA)
Bayer Identifier:
16314
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.
Inclusion Criteria
- Age 19-40 years at the time of Mirena IUD insertion - Using Mirena only for contraception indication - Never having used the product before - No heavy menstrual bleeding diagnosed - Have signed informed consent to participate in this study
Exclusion Criteria
- Nulliparous - Pregnancy - Mirena's contre-indication - Mirena for HMB - Abnormal bleeding pattern
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, Algeria | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Mirena and Amenorrhea Related acceptabILity in contraception indIcAtion
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Proportion of Mirena users who have at least one period of Amenorrhea of at least three monthsTimeframe: 12 months
- Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena usersTimeframe: 12 months
Secondary Outcome
- Proportion of Mirena users who have menstrual disordersTimeframe: 12 months
- Proportion of Mirena users with menorrhagiaTimeframe: 12 months
- Cumulative rate of satisfaction in Mirena usersTimeframe: 12 months
Additional Information
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