Clinical trial: Treatment and Management of Women With Bleeding Disorders (NCT00111215)

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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Entailment