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  • Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena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

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