Status:
COMPLETED
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
Lead Sponsor:
Bayer
Conditions:
Contraception
Menorrhagia
Eligibility:
FEMALE
23-45 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.
Detailed Description
This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Eligibility Criteria
Inclusion
- Woman currently using MIRENA for contraception or menorrhagia with duration use between 4 years 3 months and 4 years 9 months and willingness to continue with the method.
- Normal size uterus at insertion, corresponding to sound measure of 6-10 cm.
- Clinically normal cervical smear result within 12 preceding months or at screening.
- Clinically normal breast examination findings. For patients \>/= 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required.
Exclusion
- Menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms.
- Known or suspected pregnancy.
- Any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity.
- Current or recurrent pelvic inflammatory disease.
- Abnormal uterine bleeding of unknown origin.
- Acute cervicitis or vaginitis not responding to treatment.
- History of, diagnosed or suspected genital or other malignancy (excluding treated squamous cell carcinoma of the skin), and untreated cervical dysplasia.
- Any active acute liver disease or liver tumor.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00393198
Start Date
October 1 2006
End Date
October 1 2012
Last Update
November 3 2014
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Helsinki, Finland, 00100
2
Hyvinkää, Finland, 05800
3
Jyväskylä, Finland, 40100
4
Kuopio, Finland, 70110