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

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ClinicalTrials.gov Identifier: NCT00360490
Recruitment Status : Completed
First Posted : August 4, 2006
Results First Posted : November 19, 2009
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE August 2, 2006
First Posted Date  ICMJE August 4, 2006
Results First Submitted Date  ICMJE October 13, 2009
Results First Posted Date  ICMJE November 19, 2009
Last Update Posted Date December 9, 2013
Study Start Date  ICMJE July 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
  • 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 Measures  ICMJE
 (submitted: August 2, 2006)
Reduction in menstrual blood loss for patients who are diagnosed with Idiopathic Menorrhagia.
Change History Complete list of historical versions of study NCT00360490 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
  • 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 Measures  ICMJE
 (submitted: August 2, 2006)
Change in Hb, Hct and serum ferritin, patients rating of their overall improvement and menstrual bleeding profile measured by the bleeding diaries.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in Women With Idiopathic Menorrhagia to Determine the Reduction in Menstrual Blood Loss (MBL) After Treatment With the Levonorgestrel-releasing Intrauterine System (IUS)
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.
Detailed 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 HealthCare AG, Germany.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Menorrhagia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
  • Active Comparator: Medroxyprogesterone acetate (MPA)
    Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
    Intervention: Drug: Medroxyprogesterone acetate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2008)
165
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00360490
Other Study ID Numbers  ICMJE 91518
309849 ( Other Identifier: Bayer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP