NCT00883662

Brief Summary

Mirena is used for long-term in Kazakhstan, and in our observational program we would like to study patients distribution per indications of Mirena, and also patient compliance within a year after Mirena insertion. For patients with all approved indications for Mirena use: contraception, treatment of menorrhagia and protection from endometrial hyperplasia during estrogen replacement therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,725

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

4.9 years

First QC Date

April 16, 2009

Last Update Submit

September 29, 2016

Conditions

ContraceptionMenorrhagiaEndometrial HyperplasiaEstrogen Replacement Therapy

Outcome Measures

Primary Outcomes (1)

  • Patient distribution per indication

    12 months

Secondary Outcomes (1)

  • Patient compliance

    12 months

Study Arms (1)

Group 1

Drug: Levonorgestrel (Mirena, BAY86-5028)

Interventions

Levonorgestrel (Mirena, BAY86-5028)DRUG

Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

Group 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

You may qualify if:

  • Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

You may not qualify if:

  • All patients with contraindications to Mirena insertion, according to approved prescribing information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Kazakhstan

Location

MeSH Terms

Conditions

MenorrhagiaEndometrial Hyperplasia

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

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

April 16, 2009

First Posted

April 20, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2014

Study Completion

November 1, 2015

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

KA(1)