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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00111215 |
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Date of registration:
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18/05/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment and Management of Women With Bleeding Disorders
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Scientific title:
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Treatment and Management of Women With Bleeding Disorders |
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Date of first enrolment:
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January 2001 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00111215 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Nicole F Dowling, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centers for Disease Control and Prevention |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hematologic Disease
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Menorrhagia
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Von Willebrand Disease
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Blood Coagulation Disorders
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Blood Platelet Disorders
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Intervention(s)
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Drug: Desmopressin Acetate
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Drug: Tranexamic Acid
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Primary Outcome(s)
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Changes in quality of life
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Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart
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Secondary ID(s)
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CDC-NCBDDD-2906
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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