check_circleStudy Completed
Female contraception
Bayer Identifier:
16314
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Descriptive, prospective, non-interventional study (NIS) to describe Mirena and Amenorrhea related acceptability in contraception indication in medical practice
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.
Key Participants Requirements
Sex
FemaleAge
18 - 40 YearsTrial summary
Enrollment Goal
35Trial Dates
February 2013 - May 2015Phase
N/ACould I Receive a placebo
NoProducts
Mirena (Levonorgestrel IUS, BAY86-5028)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Algeria |
Primary Outcome
- Proportion of Mirena users who have at least one period of Amenorrhea of at least three monthsdate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena usersdate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Proportion of Mirena users who have menstrual disordersdate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Proportion of Mirena users with menorrhagiadate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Cumulative rate of satisfaction in Mirena usersdate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A