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Sponsored by: |
Centers for Disease Control and Prevention |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00111215 |
The purpose of the study is to determine whether oral contraceptives, desmopressin acetate, and/or tranexamic acid are effective in the treatment of women with menorrhagia who are diagnosed with a bleeding disorder.
Condition | Intervention |
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Menorrhagia Blood Coagulation Disorders Blood Platelet Disorders Von Willebrand Disease Hematologic Disease |
Drug: Tranexamic Acid Drug: Desmopressin Acetate |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Treatment and Management of Women With Bleeding Disorders |
Estimated Enrollment: | 100 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | September 2006 |
Menorrhagia is a common clinical problem. Morbid events include dysmenorrhea, hospitalizations, red blood cell transfusions, and quality of life impairment in terms of daily activities, chronic pain, and time lost from work and or school. Up to 60% of women with uncontrolled menorrhagia undergo hysterectomy. Up to 20% of women with menorrhagia may have undiagnosed von Willebrand disease (vWd), or other bleeding disorders. Prevalence of vWd in the general population is estimated at just over 1%. Intuitively, the prevalence of vWd in women with menorrhagia is probably higher since platelet plug formation is necessary for menstrual hemostasis. Current management of menorrhagia in patients in the United States often begins with hormonal therapy.
Estrogen and estrogen derivatives in oral contraceptives have been shown to increase von Willebrand factor (vWf) levels. Women with menorrhagia who have vWd or who are hemophilia A carriers have also been successfully treated with desmopressin acetate (DDAVP, Stimate® Nasal Spray). Tranexamic acid (Cyklokapron) is utilized extensively for menorrhagia in Australia and the United Kingdom. Standard hormonal therapy has not been compared with desmopressin or antifibrinolytics for menorrhagia. This study will compare treatment options for women with menorrhagia who have a detectable bleeding disorder. Investigators will document the effect on quality of life, menstrual flow, and coagulation parameters of treatment with oral contraceptive pills, desmopressin, or tranexamic acid.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Emory University School of Medicine | |
Atlanta, Georgia, United States, 30303 | |
United States, Michigan | |
Michigan State University | |
East Lansing, Michigan, United States, 48864 | |
United States, Minnesota | |
The Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New Jersey | |
UMDNJ Robert Wood Johnson Medical School | |
New Brunswick, New Jersey, United States, 08903 | |
United States, New York | |
Mary M. Gooley Hemophilia Center | |
Rochester, New York, United States, 14621 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Study Director: | Nicole F Dowling, PhD | Centers for Disease Control and Prevention |
Study ID Numbers: | CDC-NCBDDD-2906 |
Study First Received: | May 18, 2005 |
Last Updated: | March 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00111215 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Menorrhagia Von Willebrand's Disease Platelet Disorder |
Von Willebrand Disease Uterine Hemorrhage Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Vascular Diseases Uterine Diseases Tranexamic Acid Cardiovascular Agents Hemostatic Disorders Hemorrhage Hemostatics |
Arginine Vasopressin Genital Diseases, Female Thrombocytopathy Fibrin Modulating Agents Antiplasmin Antifibrinolytic Agents Hemorrhagic Disorders Genetic Diseases, Inborn Menstruation Disturbances Deamino Arginine Vasopressin Vasopressins Menorrhagia |
Molecular Mechanisms of Pharmacological Action Coagulants Hematologic Agents Physiological Effects of Drugs Tranexamic Acid Hemostatic Disorders Genital Diseases, Female Fibrin Modulating Agents Pathologic Processes Hemorrhagic Disorders Menstruation Disturbances Therapeutic Uses Cardiovascular Diseases Von Willebrand Disease Disease |
Uterine Hemorrhage Hematologic Diseases Coagulation Protein Disorders Blood Platelet Disorders Blood Coagulation Disorders Vascular Diseases Uterine Diseases Cardiovascular Agents Pharmacologic Actions Hemostatics Antifibrinolytic Agents Blood Coagulation Disorders, Inherited Genetic Diseases, Inborn Natriuretic Agents Deamino Arginine Vasopressin |