Treatment and Management of Women With Bleeding Disorders

This study has been completed.
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00111215
First received: May 18, 2005
Last updated: March 12, 2007
Last verified: June 2006
  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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111215

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
Sponsors and Collaborators
Investigators
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 July 20, 2014