Mirena Efficiency and Tolerability During the First Year of Use
Overview
In this trial the efficacy and safety of Mirena was investigated during the first year of use
Full Title of Study: “A Multicentre, Open Label, Uncontrolled Study of the Tolerance, Acceptability and Contraceptive Efficacy of Mirena 52 mg®, an Intra-uterine Levonorgestrel Device, During the First Year After Insertion Post-partum”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
Interventions
- Drug: Mirena (BAY86-5028)
- Intrauterine levonorgestrel containing device (market product)
Arms, Groups and Cohorts
- Experimental: Arm 1
Clinical Trial Outcome Measures
Primary Measures
- Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena
- Time Frame: within 12 months after randomization
Secondary Measures
- General safety assessment
- Time Frame: within 12 months after randomization
Participating in This Clinical Trial
Inclusion Criteria
- Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition). Exclusion Criteria:
- Standard exclusion criteria for use of intrauterine hormone devices
Gender Eligibility: Female
Minimum Age: 25 Years
Maximum Age: 39 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Bayer
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Bayer Study Director, Study Director, Bayer
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.