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Treatment and Management of Women With Bleeding Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00111215
Recruitment Status : Completed
First Posted : May 19, 2005
Last Update Posted : March 13, 2007
Information provided by:
Centers for Disease Control and Prevention

Brief Summary:
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 or disease Intervention/treatment Phase
Menorrhagia Blood Coagulation Disorders Blood Platelet Disorders Von Willebrand Disease Hematologic Disease Drug: Tranexamic Acid Drug: Desmopressin Acetate Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Treatment and Management of Women With Bleeding Disorders
Study Start Date : January 2001
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart
  2. Changes in quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00111215

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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
Sponsors and Collaborators
Centers for Disease Control and Prevention
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Study Director: Nicole F Dowling, PhD Centers for Disease Control and Prevention
Layout table for additonal information Identifier: NCT00111215    
Other Study ID Numbers: CDC-NCBDDD-2906
First Posted: May 19, 2005    Key Record Dates
Last Update Posted: March 13, 2007
Last Verified: June 2006
Keywords provided by Centers for Disease Control and Prevention:
Von Willebrand's Disease
Platelet Disorder
Additional relevant MeSH terms:
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Hemostatic Disorders
Hematologic Diseases
Blood Coagulation Disorders
Von Willebrand Diseases
Blood Platelet Disorders
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Menstruation Disturbances
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Deamino Arginine Vasopressin
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs