HR-QoL and Sexuality in Mirena Inserted Contraception Users
Overview
The purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use. Patients switching from oral contraception to an intrauterine contraceptive device (here: MIRENA) will be observed in the first year post MIRENA insertion.
Full Title of Study: “A Multicenter, Open Labelled, Uncontrolled, Phase IV Clinical Study to Evaluate the Health-related Quality of Life and Sexual Well-being in Young (18-35) Healthy Mirena Users Switching From OC, Over the First Year Post-insertion.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: October 2007
Interventions
- Drug: Mirena
- Mirena 52mg during 1 year
Arms, Groups and Cohorts
- Experimental: Arm 1
Clinical Trial Outcome Measures
Primary Measures
- Health-related QoL score
- Time Frame: 1 year
Secondary Measures
- Sexuality Index, treatment satisfaction, usual safety outcomes
- Time Frame: 1 year
Participating in This Clinical Trial
Inclusion Criteria
- Healthy woman willing to, or having to switch from her OC to another contraceptive method Exclusion Criteria:
- Any contraindication to Mirena insertion/use
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 35 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Bayer
- Provider of Information About this Clinical Study
- Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
- Overall Official(s)
- Bayer Study Director, Study Director, Bayer
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