Overview

This trial is active, not recruiting.

Conditions contraception, menorrhagia, endometrial hyperplasia, estrogen replacement therapy
Treatment levonorgestrel (mirena, bay86-5028)
Sponsor Bayer
Start date June 2009
End date April 2014
Trial size 2680 participants
Trial identifier NCT00883662, 14474, MA0910KZ

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
levonorgestrel (mirena, bay86-5028)
Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

Primary Outcomes

Measure
Patient distribution per indication
time frame: 12 months

Secondary Outcomes

Measure
Patient compliance
time frame: 12 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications Exclusion Criteria: - All patients with contraindications to Mirena insertion, according to approved prescribing information.

Additional Information

Official title Mirena Observational Program
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Bayer.