NCT01833793

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

1.7 years

First QC Date

March 13, 2013

Last Update Submit

September 10, 2015

Conditions

Female Contraception

Keywords

MirenaContraceptionAmenorrhea

Outcome Measures

Primary Outcomes (2)

  • Proportion of Mirena users who have at least one period of Amenorrhea of at least three months

    12 months

  • Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users

    12 months

Secondary Outcomes (3)

  • Proportion of Mirena users who have menstrual disorders

    12 months

  • Proportion of Mirena users with menorrhagia

    12 months

  • Cumulative rate of satisfaction in Mirena users

    12 months

Study Arms (1)

Group 1

Drug: Levonorgestrel IUD (Mirena, BAY86-5028)

Interventions

Levonorgestrel IUD (Mirena, BAY86-5028)DRUG

Women who have been prescribed Mirena in contraception; followed up for 12 months

Group 1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women who have been prescribed Mirena for contraception.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Algeria

Location

MeSH Terms

Conditions

Amenorrhea

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

April 17, 2013

Study Start

February 1, 2013

Primary Completion

November 1, 2014

Study Completion

May 1, 2015

Last Updated

September 14, 2015

Record last verified: 2015-09

Locations

AL(1)