Status:
COMPLETED
Treatment and Management of Women With Bleeding Disorders
Lead Sponsor:
Centers for Disease Control and Prevention
Conditions:
Menorrhagia
Blood Coagulation Disorders
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 ble...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00111215
Start Date
January 1 2001
End Date
September 1 2006
Last Update
March 13 2007
Active Locations (6)
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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