Trial Condition(s):

Idiopathic Menorrhagia

Mirena in idiopathic Menorrhagia

Bayer Identifier:

14494

ClinicalTrials.gov Identifier:

NCT00868153

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.

Inclusion Criteria
-  Woman diagnosed with idiopathic Menorrhagia according to assessment of the investigator and according to international guidelines. These woman should also accept to be on contraception during the time period that they have Mirena in situ.
 - Age limit 30-45
 - BMI= 18-34
 - Signed informed consent
Exclusion Criteria
- Medical conditions featured in the Mirena data sheet (See Appendix 1) that contraindicate its use, listed below:
 - Known or suspected pregnancy; current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product. 
 - Nulliparity 
 - Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication  that could effect bleeding  should be stopped at least 3 months before the first visit and should not be used during the course of the study.         
 - History of diabetes mellitus,cardiovascular disease and thyroid abnormalities
 - Anticoagulation therapy
 - Cancer history including breast cancer.

Trial Summary

Enrollment Goal
1125
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Bulgaria

Status
Completed
 
Locations

Investigative Site

Many Locations, Croatia

Status
Completed
 
Locations

Investigative Site

Many Locations, Pakistan

Status
Completed
 
Locations

Investigative Site

Many Locations, Romania

Status
Completed
 
Locations

Investigative Site

Many Locations, Saudi Arabia

Status
Completed
 
Locations

Investigative Site

Many Locations, Jordan

Status
Completed
 
Locations

Investigative Site

Many Locations, United Arab Emirates

Status
Completed
 
Locations

Investigative Site

Many Locations, Turkey

Status
Completed
 
Locations

Investigative Site

Many Locations, Russia

Status
Completed
 
Locations

Investigative Site

Many Locations, India

Status
Completed
 
Locations

Investigative Site

Many Locations, Serbia

Status
Completed
 
Locations

Investigative Site

Many Locations, Sri Lanka

Status
Completed
 
Locations

Investigative Site

Many Locations, Kuwait

Status
Completed
 

Trial Design