Clinical trial NCT00111215: Treatment and Management of Women With Bleeding Disorders
Official title: Treatment and Management of Women With Bleeding Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Blood Coagulation Disorders
Blood Platelet Disorders
Von Willebrand Disease
Hematologic Disease
Keywords: Menorrhagia
Von Willebrand's Disease
Platelet Disorder
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-05-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: 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.

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 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

Primary outcomes:
measure: Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart
measure: Changes in quality of life
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Rochester
country: United States
facility: The Mayo Clinic
state: Minnesota
city: New Brunswick
country: United States
facility: UMDNJ Robert Wood Johnson Medical School
state: New Jersey
city: Rochester
country: United States
facility: Mary M. Gooley Hemophilia Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Nicole F Dowling, PhD
role: STUDY_DIRECTOR
References: