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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

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

Condition or disease Intervention/treatment Phase
Menorrhagia Drug: Levonorgestrel IUS (Mirena, BAY86-5028) Drug: Medroxyprogesterone acetate Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Levonorgestrel IUS (Mirena, BAY86-5028)
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.
 Drug: Medroxyprogesterone acetate
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group [ Time Frame: Baseline and up to 6 months ]
  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Percent Change in Hemoglobin [ Time Frame: Baseline and up to 6 months ]
  10. Percent Change in Hematocrit [ Time Frame: Baseline and up to 6 months ]
  11. Percent Change in Serum Ferritin [ Time Frame: Baseline and up to 6 months ]
  12. 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'

  13. 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'.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360490


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Publications of Results:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00360490    
Obsolete Identifiers: NCT00360620
Other Study ID Numbers: 91518
309849 ( Other Identifier: Bayer )
First Posted: August 4, 2006    Key Record Dates
Results First Posted: November 19, 2009
Last Update Posted: December 9, 2013
Last Verified: November 2013
Keywords provided by Bayer:
Idiopathic Menorrhagia
Additional relevant MeSH terms:
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Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Hemorrhage
Pathologic Processes
Menstruation Disturbances
Medroxyprogesterone Acetate
Levonorgestrel
Medroxyprogesterone
Contraceptive Agents, Hormonal
 Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Hormonal
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents