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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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 HealthCare AG, Germany.


Sponsor: Bayer

Current Primary Outcome:

  • 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 ]
    The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase.
  • Percentage of Patients With Successful Treatment [ Time Frame: At 6 months ]
    End-of-study MBL < 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success.


Original Primary Outcome: Reduction in menstrual blood loss for patients who are diagnosed with Idiopathic Menorrhagia.

Current Secondary Outcome:

  • Percent Change From Baseline MBL to End of Study MBL (Cycle 6) [ Time Frame: Baseline and up to 6 months ]
    The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100.
  • Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3) [ Time Frame: Baseline and up to 3 months ]
    The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase.
  • Percent Change From Baseline MBL to Mid-study MBL (Cycle 3) [ Time Frame: Baseline and up to 3 months ]
    The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100.
  • Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group [ Time Frame: Baseline and up to 6 months ]
  • Total Number of Bleeding Days [ Time Frame: Baseline and up to 6 months ]
    In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
  • Total Number of Spotting and Bleeding Days [ Time Frame: Baseline and up to 6 months ]
    In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
  • Total Number of Spotting Days [ Time Frame: Baseline and up to 6 months ]
    In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
  • Total Number of Bleeding Episodes [ Time Frame: Baseline and up to 6 months ]
    A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts.
  • Percent Change in Hemoglobin [ Time Frame: Baseline and up to 6 months ]
  • Percent Change in Hematocrit [ Time Frame: Baseline and up to 6 months ]
  • Percent Change in Serum Ferritin [ Time Frame: Baseline and up to 6 months ]
  • Percentage of Patients With Improvement in the Investigator Global Assessment Scale [ Time Frame: Up to 6 months ]
    "Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'
  • Percentage of Patients With Improvement in the Patients Overall Assessment Scale [ Time Frame: Up to 6 months ]
    "Improved" is classified as 'very much improved', 'much improved', or 'improved' and "not improved" is classified as 'no change', 'worse', 'much worse', or 'very much worse'.


Original Secondary Outcome: Change in Hb, Hct and serum ferritin, patients rating of their overall improvement and menstrual bleeding profile measured by the bleeding diaries.

Information By: Bayer

Dates:
Date Received: August 2, 2006
Date Started: July 2006
Date Completion:
Last Updated: November 14, 2013
Last Verified: November 2013