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:

NCT01833793

EudraCT Number:

Not Available

Study Completed

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
35
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Algeria

Status
Completed
 

Trial Design