Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)

Verified by: Bayer, November 2011
First Received: August 2, 2006 | Last Updated: November 3, 2011 | Phase: Phase 3 | Start Date: July 2006
Overall Status: Completed | Estimated Enrollment: 165
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The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss...

Brief Summary

Official Title: “A Multicenter, Randomized, Open Label, Parallel Group, Active Control Study to Evaluate the Efficacy and Safety of LNG IUS (Mirena®) as Compared to Medroxyprogesterone Acetate During 6 Cycles of Treatment in Patients With Idiopathic Menorrhagia”

The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: June 2008

Detailed Clinical Trial Description

Acronyms in the Adverse Event Section: - IUCD Intrauterine Contraceptive Device - MedDRA Medical Dictionary for Regulatory Activities

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc.

has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany.

Intervention(s) in this Clinical Trial

  • Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
    • Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
  • Drug: Medroxyprogesterone acetate
    • Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Levonorgestrel Intrauterine System (LNG IUS) 20µg per 24 hours
    • Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
  • Active Comparator: Medroxyprogesterone acetate (MPA)
    • Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Outcome Measures for this Clinical Trial

Primary Measures

  • The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)
    • Time Frame: Baseline and up to 6 months
      Safety Issue?: No
  • Percentage of Patients With Successful Treatment
    • Time Frame: At 6 months
      Safety Issue?: No

Secondary Measures

  • Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
    • Time Frame: Baseline and up to 6 months
      Safety Issue?: No
  • Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)
    • Time Frame: Baseline and up to 3 months
      Safety Issue?: No
  • Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
    • Time Frame: Baseline and up to 3 months
      Safety Issue?: No
  • Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
    • Time Frame: Baseline and up to 6 months
      Safety Issue?: No
  • Total Number of Bleeding Days
    • Time Frame: Baseline and up to 6 months
      Safety Issue?: No
  • Total Number of Spotting and Bleeding Days
    • Time Frame: Baseline and up to 6 months
      Safety Issue?: No
  • Total Number of Spotting Days
    • Time Frame: Baseline and up to 6 months
      Safety Issue?: No
  • Total Number of Bleeding Episodes
    • Time Frame: Baseline and up to 6 months
      Safety Issue?: No
  • Percent Change in Hemoglobin
    • Time Frame: Baseline and up to 6 months
      Safety Issue?: No
  • Percent Change in Hematocrit
    • Time Frame: Baseline and up to 6 months
      Safety Issue?: No
  • Percent Change in Serum Ferritin
    • Time Frame: Baseline and up to 6 months
      Safety Issue?: No
  • Percentage of Patients With Improvement in the Investigator Global Assessment Scale
    • Time Frame: Up to 6 months
      Safety Issue?: No
  • Percentage of Patients With Improvement in the Patients Overall Assessment Scale
    • Time Frame: Up to 6 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Women who have >/= 80 mL blood loss during their menstrual cycles and desire contraception

Exclusion Criteria:

  • Post menopausal menstrual cycle < 21 days or > 35 days
  • Pregnancy

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00360490

Study ID Number: 91518

ClinicalTrials.gov Identifier: NCT00360490

Health Authority: United States: Food and Drug Administration

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