check_circleStudy Completed

Menorrhagia

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

Female

Age

18 Years
  • - Women who have >/= 80 mL blood loss during their menstrual cycles and desire contraception


  • - Post menopausal menstrual cycle < 21 days or > 35 days
    - Pregnancy

Trial summary

Enrollment Goal
165
Trial Dates
July 2006 - June 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Eastern Virginia Medical SchoolNorfolk, 23507, United States
Completed
Northern Indiana Womens Heatlh Research, Inc.South Bend, 46601, United States
Completed
Boston University School of MedicineBoston, 02118, United States
Completed
Genesis Center for Clinical ResearchSan Diego, 92103, United States
Completed
Visions Clinical Research - TucsonTucson, 85712, United States
Completed
Oregon Health and Science UniversityPortland, 97239, United States
Completed
Fletcher Allen Health CareBurlington, 05401, United States
Completed
University of Florida Women's Health- Specialists EmersonJacksonville, 32216, United States
Completed
South Carolina Clinical Research CenterColumbia, 29201, United States
Completed
Harbor - UCLA Medical CenterTorrance, 90509, United States
Completed
Advances in Health, inc.Houston, 77030, United States
Terminated
Synergy Medical Education AllianceSaginaw, 48602, United States
Completed
Lyndhurst Gynecologic AssociatesWinston-Salem, 27103, United States
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Completed
Comprehensive Clinical TrialsWest Palm Beach, 33409, United States
Completed
Visions Clinical ResearchBoynton Beach, 33437, United States
Completed
University of Medicine and Dentistry of New JerseyNew Brunswick, 08901, United States
Terminated
Laurel Creek Research AssociatesMoorestown, 08057, United States
Completed
Seattle Women's: Health, Research, GynecologySeattle, 98105, United States
Completed
York Clinical ConsultingMarrero, 70072, United States
Terminated
Woman’s Clinical ResearchNewburgh, 47630, United States
Completed
Clinical Trials Research Services, LLCPittsburgh, 15206, United States
Completed
Blue Hill Medical GroupSanta Monica, 90403, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
Phoenix Ob-Gyn AssoicatesMoorestown, 08057, United States
Completed
Center for Women's ResearchChicago, 60612, United States
Completed
Women's Clinic of Lincoln, PCLincoln, 68510, United States
Completed
Impact Clinical TrialsBeverly Hills, 90211, United States
Completed
Yassear Clinical ResearchCarmichael, 95608, United States
Completed
Clinical Trial Center of ColoradoLittleton, 80122, United States
Completed
New South MedicalClarksville, 37043, United States
Completed
Affiliated Clinical Research, Inc.Las Vegas, United States
Completed
York Clinical ConsultingAmite, 70422, United States
Terminated
Obstetrical & Gynecological Associates, PAHouston, United States
Completed
St. Louis Women's Health Care GroupChesterfield, 63017, United States
Completed
Providence Medical Group/OB-GYN Health CenterMedford, 97504, United States
Completed
Research AssociatesBoise, 83702, United States
Completed
Affiliated Clinical Research, Inc.LasVegas, 89106, United States
Completed
Clinique de GynecologieShawinigan, G9N 2H6, Canada
Completed
Ottawa Hospital-Riverside CampusOttawa, 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 ResearchToronto, M4S 1Y2, Canada
Completed
Kells Medical Research Group, Inc.Pointe-Claire, H9R 4S3, Canada
Completed
Centre for Kinesiology, Health and SportRegina, S4S 0A2, Canada
Completed
Les Gynecologues AssociesMontreal, H2X 1N8, Canada
Completed
Maritimes Research CenterBathurst, E2A 4X7, Canada
Completed
Omnispec Recherche Clinique Inc.Mirabel, J7J 1L2, Canada
Completed
Faculdade de Ciencias Medicas-Universidade Estadual CampinasCampinas, 13083-970, Brazil
Completed
Centro de Estudos e Pesquisas em Reproducao Humana e Fertil.Curitiba, 80030-220, Brazil
Terminated
Hospital Italiano Buenos AiresBuenos Aires, C1181ACH, Argentina
Completed
Hospital Bernardino RivadaviaBuenos Aires, 1425, Argentina
Completed
Hospital General de México SSMexico, 16720, Mexico
Completed
Hospital Universitario "José Eleuterio González"Monterrey, 64460, Mexico
Completed
Instituto Nacional de PerinatologíaMEXICO 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 months
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Patients With Successful Treatment
    date_rangeTime Frame:
    At 6 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
    date_rangeTime Frame:
    Baseline and up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)
    date_rangeTime Frame:
    Baseline and up to 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
    date_rangeTime Frame:
    Baseline and up to 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
    date_rangeTime Frame:
    Baseline and up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Total Number of Bleeding Days
    date_rangeTime Frame:
    Baseline and up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Total Number of Spotting and Bleeding Days
    date_rangeTime Frame:
    Baseline and up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Total Number of Spotting Days
    date_rangeTime Frame:
    Baseline and up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Total Number of Bleeding Episodes
    date_rangeTime Frame:
    Baseline and up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Percent Change in Hemoglobin
    date_rangeTime Frame:
    Baseline and up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Percent Change in Hematocrit
    date_rangeTime Frame:
    Baseline and up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Percent Change in Serum Ferritin
    date_rangeTime Frame:
    Baseline and up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Patients With Improvement in the Investigator Global Assessment Scale
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of Patients With Improvement in the Patients Overall Assessment Scale
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2