Trial Condition(s):
Contraception, Menorrhagia, Endometrial Hyperplasia, Estrogen replacement therapy
Mirena observational program
Bayer Identifier:
14474
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
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
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.
Trial Summary
Enrollment Goal
2725
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Kazakhstan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Mirena observational program
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Patient distribution per indicationTimeframe: 12 months
Secondary Outcome
- Patient complianceTimeframe: 12 months
Additional Information
Copyright © Bayer
Powered by
