check_circleStudy Completed
Menorrhagia
Bayer Identifier:
91518
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study in women with Idiopathic Menorrhagia to determine the reduction in menstrual blood loss (MBL) after treatment with the levonorgestrel-releasing intrauterine system (IUS)
Trial purpose
The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.
Key Participants Requirements
Sex
FemaleAge
18 YearsTrial summary
Enrollment Goal
165Trial Dates
July 2006 - June 2008Phase
Phase 3Could I Receive a placebo
NoProducts
Mirena (Levonorgestrel IUS, BAY86-5028)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Eastern Virginia Medical School | Norfolk, 23507, United States |
Completed | Northern Indiana Womens Heatlh Research, Inc. | South Bend, 46601, United States |
Completed | Boston University School of Medicine | Boston, 02118, United States |
Completed | Genesis Center for Clinical Research | San Diego, 92103, United States |
Completed | Visions Clinical Research - Tucson | Tucson, 85712, United States |
Completed | Oregon Health and Science University | Portland, 97239, United States |
Completed | Fletcher Allen Health Care | Burlington, 05401, United States |
Completed | University of Florida Women's Health- Specialists Emerson | Jacksonville, 32216, United States |
Completed | South Carolina Clinical Research Center | Columbia, 29201, United States |
Completed | Harbor - UCLA Medical Center | Torrance, 90509, United States |
Completed | Advances in Health, inc. | Houston, 77030, United States |
Terminated | Synergy Medical Education Alliance | Saginaw, 48602, United States |
Completed | Lyndhurst Gynecologic Associates | Winston-Salem, 27103, United States |
Completed | Clinical Research of Philadelphia, LLC | Philadelphia, 19114, United States |
Completed | Comprehensive Clinical Trials | West Palm Beach, 33409, United States |
Completed | Visions Clinical Research | Boynton Beach, 33437, United States |
Completed | University of Medicine and Dentistry of New Jersey | New Brunswick, 08901, United States |
Terminated | Laurel Creek Research Associates | Moorestown, 08057, United States |
Completed | Seattle Women's: Health, Research, Gynecology | Seattle, 98105, United States |
Completed | York Clinical Consulting | Marrero, 70072, United States |
Terminated | Woman’s Clinical Research | Newburgh, 47630, United States |
Completed | Clinical Trials Research Services, LLC | Pittsburgh, 15206, United States |
Completed | Blue Hill Medical Group | Santa Monica, 90403, United States |
Completed | Medical Center for Clinical Research | San Diego, 92108, United States |
Completed | Phoenix Ob-Gyn Assoicates | Moorestown, 08057, United States |
Completed | Center for Women's Research | Chicago, 60612, United States |
Completed | Women's Clinic of Lincoln, PC | Lincoln, 68510, United States |
Completed | Impact Clinical Trials | Beverly Hills, 90211, United States |
Completed | Yassear Clinical Research | Carmichael, 95608, United States |
Completed | Clinical Trial Center of Colorado | Littleton, 80122, United States |
Completed | New South Medical | Clarksville, 37043, United States |
Completed | Affiliated Clinical Research, Inc. | Las Vegas, United States |
Completed | York Clinical Consulting | Amite, 70422, United States |
Terminated | Obstetrical & Gynecological Associates, PA | Houston, United States |
Completed | St. Louis Women's Health Care Group | Chesterfield, 63017, United States |
Completed | Providence Medical Group/OB-GYN Health Center | Medford, 97504, United States |
Completed | Research Associates | Boise, 83702, United States |
Completed | Affiliated Clinical Research, Inc. | LasVegas, 89106, United States |
Completed | Clinique de Gynecologie | Shawinigan, G9N 2H6, Canada |
Completed | Ottawa Hospital-Riverside Campus | Ottawa, K1H7W9, Canada |
Completed | Clinique Recherche en Sante des Femmes Inc. | Quebec, G1S 2L6, Canada |
Completed | Centre d'étude clinique de Montréal Inc. | Montreal, H1T 1P6, Canada |
Completed | Prime Health Research | Toronto, M4S 1Y2, Canada |
Completed | Kells Medical Research Group, Inc. | Pointe-Claire, H9R 4S3, Canada |
Completed | Centre for Kinesiology, Health and Sport | Regina, S4S 0A2, Canada |
Completed | Les Gynecologues Associes | Montreal, H2X 1N8, Canada |
Completed | Maritimes Research Center | Bathurst, E2A 4X7, Canada |
Completed | Omnispec Recherche Clinique Inc. | Mirabel, J7J 1L2, Canada |
Completed | Faculdade de Ciencias Medicas-Universidade Estadual Campinas | Campinas, 13083-970, Brazil |
Completed | Centro de Estudos e Pesquisas em Reproducao Humana e Fertil. | Curitiba, 80030-220, Brazil |
Terminated | Hospital Italiano Buenos Aires | Buenos Aires, C1181ACH, Argentina |
Completed | Hospital Bernardino Rivadavia | Buenos Aires, 1425, Argentina |
Completed | Hospital General de México SS | Mexico, 16720, Mexico |
Completed | Hospital Universitario "José Eleuterio González" | Monterrey, 64460, Mexico |
Completed | Instituto Nacional de Perinatología | MEXICO DF, 11000, Mexico |
Primary Outcome
- The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)date_rangeTime Frame:Baseline and up to 6 monthsenhanced_encryptionNoSafety Issue:
- Percentage of Patients With Successful Treatmentdate_rangeTime Frame:At 6 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Percent Change From Baseline MBL to End of Study MBL (Cycle 6)date_rangeTime Frame:Baseline and up to 6 monthsenhanced_encryptionNoSafety Issue:
- Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)date_rangeTime Frame:Baseline and up to 3 monthsenhanced_encryptionNoSafety Issue:
- Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)date_rangeTime Frame:Baseline and up to 3 monthsenhanced_encryptionNoSafety Issue:
- Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Groupdate_rangeTime Frame:Baseline and up to 6 monthsenhanced_encryptionNoSafety Issue:
- Total Number of Bleeding Daysdate_rangeTime Frame:Baseline and up to 6 monthsenhanced_encryptionNoSafety Issue:
- Total Number of Spotting and Bleeding Daysdate_rangeTime Frame:Baseline and up to 6 monthsenhanced_encryptionNoSafety Issue:
- Total Number of Spotting Daysdate_rangeTime Frame:Baseline and up to 6 monthsenhanced_encryptionNoSafety Issue:
- Total Number of Bleeding Episodesdate_rangeTime Frame:Baseline and up to 6 monthsenhanced_encryptionNoSafety Issue:
- Percent Change in Hemoglobindate_rangeTime Frame:Baseline and up to 6 monthsenhanced_encryptionNoSafety Issue:
- Percent Change in Hematocritdate_rangeTime Frame:Baseline and up to 6 monthsenhanced_encryptionNoSafety Issue:
- Percent Change in Serum Ferritindate_rangeTime Frame:Baseline and up to 6 monthsenhanced_encryptionNoSafety Issue:
- Percentage of Patients With Improvement in the Investigator Global Assessment Scaledate_rangeTime Frame:Up to 6 monthsenhanced_encryptionNoSafety Issue:
- Percentage of Patients With Improvement in the Patients Overall Assessment Scaledate_rangeTime Frame:Up to 6 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2