Scandinavian Mirena Insertion Nulliparous Trial.
- Registration Number
- NCT00798980
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 224
Inclusion Criteria
- Nulliparous women Mirena insertion planned as contraceptive method
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm 1 Mirena (BAY86-5028) -
- Primary Outcome Measures
Name Time Method Evaluation of the insertion procedure of Mirena in nulliparous women At the insertion time point
- Secondary Outcome Measures
Name Time Method Continuation rate 12-16 weeks post insertion Pain At the insertion time point Bleeding Pattern 12-16 weeks post insertion Satisfaction 12-16 weeks post insertion