Treatment and Management of Women With Bleeding Disorders

Sponsor

Centers for Disease Control and Prevention (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00111215

Collaborator

(none)

100

Enrollment

Locations

Duration (Months)

16.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2001

Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart []
Changes in quality of life []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Emory University School of Medicine	Atlanta	Georgia	United States	30303
2	Michigan State University	East Lansing	Michigan	United States	48864
3	The Mayo Clinic	Rochester	Minnesota	United States	55905
4	UMDNJ Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
5	Mary M. Gooley Hemophilia Center	Rochester	New York	United States	14621
6	Duke University Medical Center	Durham	North Carolina	United States	27710