Mirena Observational Program

Contraception Clinical Trial

Official title:

Mirena Observational Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883662
• Other study ID #: 14474
• Secondary ID: MA0910KZ
• Status: Completed
• Phase: N/A
• First received: April 16, 2009
• Last updated: September 29, 2016
• Start date: May 2009
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kazakhstan: National Center for Expertise of Medicinal Drugs
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2725
• Est. completion date: November 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception
• Endometrial Hyperplasia
• Estrogen Replacement Therapy
• Hyperplasia
• Menorrhagia

Intervention

Drug:
• Levonorgestrel (Mirena, BAY86-5028)
Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient distribution per indication		12 months	No
Secondary	Patient compliance		12 months	No

External Links

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