Treatment and Management of Women With Bleeding Disorders

Completed · Not applicable

Conditions studied: Menorrhagia, Blood Coagulation Disorders, Blood Platelet Disorders, Von Willebrand Disease, Hematologic Disease

In brief

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.

Key facts

Study ID

NCT00111215

Run by

Centers for Disease Control and Prevention

People needed

100

Starts

2001-01-01

Expected to finish

2006-09-01

Last updated by the study team

2007-03-13

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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