Treatment and Management of Women With Bleeding Disorders
1 other identifier
interventional
100
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2001
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 18, 2005
CompletedFirst Posted
Study publicly available on registry
May 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedMarch 13, 2007
June 1, 2006
May 18, 2005
March 12, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction of menstrual blood loss as measured by a Pictorial Self-Assessment Chart
Changes in quality of life
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Emory University School of Medicine
Atlanta, Georgia, 30303, United States
Michigan State University
East Lansing, Michigan, 48864, United States
The Mayo Clinic
Rochester, Minnesota, 55905, United States
UMDNJ Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
Mary M. Gooley Hemophilia Center
Rochester, New York, 14621, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nicole F Dowling, PhD
Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
Study Record Dates
First Submitted
May 18, 2005
First Posted
May 19, 2005
Study Start
January 1, 2001
Study Completion
September 1, 2006
Last Updated
March 13, 2007
Record last verified: 2006-06