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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