Treatment and Management of Women With Bleeding Disorders
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.
Description
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.
Status: Completed (N/A). Started on January 1st, 2001. Ended on September 1st, 2006.
Enrollment: 100 subjects
Study Type: Interventional
Study Design:
- Prevention
- Randomized
- Open Label
- Active Control
- Crossover Assignment
- Efficacy Study
Conditions:
- Menorrhagia
- Blood Coagulation Disorders
- Blood Platelet Disorders
- Von Willebrand Disease
- Hematologic Disease
Interventions:
- Drug: Tranexamic Acid
- Drug: Desmopressin Acetate
Eligibility
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
- Gender
Female
- Mininum Age
18 Years
- Maximum Age
50 Years
- Healthy Volunteers
No
Resources
Source: Centers for Disease Control and Prevention
Authority: United States: Food and Drug Administration
Locations
-
Emory University School of Medicine
Atlanta
Georgia
30303
United States
-
Michigan State University
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
Officials
Nicole F Dowling, PhD (Study Director, Centers for Disease Control and Prevention)
Sponsors
Centers for Disease Control and Prevention (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- June 1st, 2006
- First Received
- March 12th, 2007
- Last Changed
- March 12th, 2007
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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