Treatment and Management of Women With Bleeding Disorders

Menorrhagia Clinical Trial

Official title:

Treatment and Management of Women With Bleeding Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111215
• Other study ID #: CDC-NCBDDD-2906
• Status: Completed
• Phase: N/A
• First received: May 18, 2005
• Last updated: March 12, 2007
• Start date: January 2001
• Est. completion date: September 2006

Study information

• Verified date: June 2006
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Blood Platelet Disorders
• Disease
• Hematologic Disease
• Hematologic Diseases
• Hemostatic Disorders
• Menorrhagia
• Von Willebrand Disease
• Von Willebrand Diseases

Intervention

Drug:
• Tranexamic Acid

• Desmopressin Acetate

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Duke University Medical Center	Durham	North Carolina
United States	Michigan State University	East Lansing	Michigan
United States	UMDNJ Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Mary M. Gooley Hemophilia Center	Rochester	New York
United States	The Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart
Primary	Changes in quality of life