Status:
COMPLETED
Scandinavian Mirena Insertion Nulliparous Trial.
Lead Sponsor:
Bayer
Conditions:
Nulliparous
Eligibility:
FEMALE
14+ years
Brief Summary
In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.
Eligibility Criteria
Inclusion
- Nulliparous women Mirena insertion planned as contraceptive method
Exclusion
- Ongoing or suspected pregnancy;
- Ongoing or recidivating genital infection;
- Cervicitis;
- Cervical dysplasia;
- Malignancy in uterus or cervix;
- Confirmed or suspected hormone sensitive neoplasia including breast cancer
- Undiagnosed abnormal uterine bleeding;
- Uterine anomaly including myoma if the cavity of the uterus is restricted;
- Conditions that cause increased risk of infections;
- Acute liver disease or liver tumour;
- Allergy to the active substance or any component of the IUD
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00798980
Start Date
February 1 2007
End Date
November 1 2009
Last Update
April 22 2015
Active Locations (1)
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1
Many Locations, Sweden