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