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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | |||
| Desmopressin Acetate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart | ||
| Changes in quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole F Dowling, PhD | Centers for Disease Control and Prevention | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Medicine | Atlanta | Georgia | 30303 | United States | ||
| Michigan State University |
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| East Lansing |
| Michigan |
| 48864 |
| United States |
| The Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| UMDNJ Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| Mary M. Gooley Hemophilia Center | Rochester | New York | 14621 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| D001778 | Blood Coagulation Disorders |
| D001791 | Blood Platelet Disorders |
| D014842 | von Willebrand Diseases |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D006425 | Hemic and Lymphatic Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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