Treatment and Management of Women With Bleeding Disorders
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Purpose
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 |
|---|---|
|
Menorrhagia Blood Coagulation Disorders Blood Platelet Disorders Von Willebrand Disease Hematologic Disease |
Drug: Tranexamic Acid Drug: Desmopressin Acetate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Treatment and Management of Women With Bleeding Disorders |
- Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart
- Changes in quality of life
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Referred to study by gynecologist or internist/family practitioner with diagnosis of menorrhagia or referred by self through community advertising or networking
- Prospective pictorial chart scores of menses >100
- Negative pelvic exam and Pap smear within the past year. *Ultrasound if manual exam indicates abnormal uterine size; *Endometrial biopsy if >35 and non-cyclic bleeding; *Rule out acute pelvic diseases – gonorrhea, chlamydia
- Age 18-50
- Willing to go off oral contraceptives and selected drugs (including some nutritional supplements and drugs that affect coagulation such as aspirin and ibuprofen) for initial laboratory testing and throughout the cross-over drug portion of the study
- Periods at least every 39 days
Exclusion Criteria:
- Patient is not proficient in English
- Patient is pregnant
- Patient on hormone replacement, Depo-Provera, or Norplant in last three months
- Patient has intrauterine device (IUD) present
- Patient is taking warfarin sodium (Coumadin) or other anti-coagulation therapy
- History of documented vascular disease (coronary artery disease, cerebrovascular disease or stroke, transient ischemic attack, peripheral vascular disease)
- Uncontrolled hypertension
- Insulin dependent diabetes mellitus
- Chronic renal or liver disease
- History of seizure disorder
- History of cancer (other than non-invasive skin cancer)
- History of venous or arterial thromboembolism
- Patient with a previously diagnosed bleeding disorder has taken or is taking desmopressin acetate or antifibrinolytic drugs for treatment of heavy menstrual bleeding
Contacts and Locations| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00111215 History of Changes |
| Other Study ID Numbers: | CDC-NCBDDD-2906 |
| Study First Received: | May 18, 2005 |
| Last Updated: | March 12, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Centers for Disease Control and Prevention:
|
Menorrhagia Von Willebrand's Disease Platelet Disorder |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Blood Platelet Disorders Hematologic Diseases Hemorrhage Menorrhagia Von Willebrand Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Menstruation Disturbances |
Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Genetic Diseases, Inborn Deamino Arginine Vasopressin Tranexamic Acid Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Cardiovascular Agents Antifibrinolytic Agents |
ClinicalTrials.gov processed this record on May 23, 2013