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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00360490
First received: August 2, 2006
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Percent Change From Baseline MBL to End of Study MBL (Cycle 6) [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Total Number of Bleeding Days [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percent Change in Hematocrit [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  • Percent Change in Serum Ferritin [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  • Percentage of Patients With Improvement in the Investigator Global Assessment Scale [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    "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 ] [ Designated as safety issue: No ]
    "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'.


Enrollment: 165
Study Start Date: July 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360490

  Hide Study Locations
Locations
United States, Arizona
Tucson, Arizona, United States, 85712
United States, California
Beverly Hills, California, United States, 90211
Carmichael, California, United States, 95608
San Diego, California, United States, 92103
San Diego, California, United States, 92108
Santa Monica, California, United States, 90403
Torrance, California, United States, 90509
United States, Colorado
Littleton, Colorado, United States, 80122
United States, Florida
Boynton Beach, Florida, United States, 33437
Jacksonville, Florida, United States, 32216
West Palm Beach, Florida, United States, 33409
United States, Idaho
Boise, Idaho, United States, 83702
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Indiana
Newburgh, Indiana, United States, 47630
South Bend, Indiana, United States, 46601
United States, Louisiana
Amite, Louisiana, United States, 70422
Marrero, Louisiana, United States, 70072
United States, Massachusetts
Boston, Massachusetts, United States, 02118
United States, Michigan
Saginaw, Michigan, United States, 48602
United States, Missouri
Chesterfield, Missouri, United States, 63017
United States, Nebraska
Lincoln, Nebraska, United States, 68510
United States, Nevada
Las Vegas, Nevada, United States
LasVegas, Nevada, United States, 89106
United States, New Jersey
Moorestown, New Jersey, United States, 08057
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Medford, Oregon, United States, 97504
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19114
Pittsburgh, Pennsylvania, United States, 15206
United States, South Carolina
Columbia, South Carolina, United States, 29201
United States, Tennessee
Clarksville, Tennessee, United States, 37043
United States, Texas
Houston, Texas, United States, 77030
Houston, Texas, United States
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Norfolk, Virginia, United States, 23507
United States, Washington
Seattle, Washington, United States, 98105
Argentina
Buenos Aires, Argentina, C1181ACH
Buenos Aires, Argentina, 1425
Brazil
Curitiba, Parana, Brazil, 80030-220
Campinas, Sao Paulo, Brazil, 13083-970
Canada, New Brunswick
Bathurst, New Brunswick, Canada, E2A 4X7
Canada, Ontario
Ottawa, Ontario, Canada, K1H7W9
Toronto, Ontario, Canada, M4S 1Y2
Canada, Quebec
Mirabel, Quebec, Canada, J7J 1L2
Montreal, Quebec, Canada, H2X 1N8
Montreal, Quebec, Canada, H1T 1P6
Pointe-Claire, Quebec, Canada, H9R 4S3
Shawinigan, Quebec, Canada, G9N 2H6
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4S 0A2
Canada
Quebec, Canada, G1S 2L6
Mexico
Mexico, México, Mexico, 16720
Monterrey, Nuevo Leon, Mexico, 64460
Mexico Df, Mexico, 11000
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00360490     History of Changes
Obsolete Identifiers: NCT00360620
Other Study ID Numbers: 91518, 309849
Study First Received: August 2, 2006
Results First Received: October 13, 2009
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Idiopathic Menorrhagia

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Levonorgestrel
Medroxyprogesterone
Medroxyprogesterone Acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 26, 2014