Healia Clinical Trials Information Database

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:

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.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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