check_circleStudy Completed

Female contraception

Bayer Identifier:

16314

ClinicalTrials.gov Identifier:

NCT01833793

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

Female

Age

18 - 40 Years
  • - 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

  • - Nulliparous
    - Pregnancy
    - Mirena's contre-indication
    - Mirena for HMB
    - Abnormal bleeding pattern

Trial summary

Enrollment Goal
35
Trial Dates
February 2013 - May 2015
Phase
N/A
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Algeria

Primary Outcome

  • Proportion of Mirena users who have at least one period of Amenorrhea of at least three months
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Proportion of Mirena users who have menstrual disorders
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of Mirena users with menorrhagia
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No
  • Cumulative rate of satisfaction in Mirena users
    date_rangeTime Frame:
    12 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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