Mirena Observational Program

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00883662
• Collaborator: (none)
• Enrollment: 2,725
• Location: 1
• Duration (Months): 78
• Patients Per Site Per Month: 34.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Contraception; Menorrhagia; Endometrial Hyperplasia; Estrogen Replacement Therapy	Drug: Levonorgestrel (Mirena, BAY86-5028)

Study Design

• Study Type: Observational
• Actual Enrollment: 2725 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Mirena Observational Program
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: Levonorgestrel (Mirena, BAY86-5028); Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

Outcome Measures

Primary Outcome Measures

1. Patient distribution per indication [12 months]

Secondary Outcome Measures

1. Patient compliance [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Kazakhstan

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00883662
• Other Study ID Numbers: 14474; MA0910KZ
• First Posted: Apr 20, 2009
• Last Update Posted: Sep 30, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Menorrhagia; Endometrial Hyperplasia; Hyperplasia; Levonorgestrel

Study Results

No Results Posted as of Sep 30, 2016