Open Label Continuation Study for the Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
The high percentage of failure using available non-surgical options to treat menorrhagia in women with bleeding disorders shows a continuing need for innovative treatments. This has led to development of this protocol in order to make available tranexamic acid as a potentially effective menorrhagia therapy option in women with an underlying bleeding disorder. We anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in bleeding disorder patients.
Description
Women with heavy periods and with a diagnosed bleeding disorders are prescribed cyclokapron pills to be taken during their periods. Their periods are assessed at 3 and 6 months by filling out a pictorial blood assessment chart. If the drug appears to be working with no adverse effects the patients can continue to take the medication as long as it is available with follow up with the investigator every 6 months.
Status: Completed (N/A). Started on April 1st, 2003. Ended on June 1st, 2008.
Enrollment: 13 subjects
Study Type: Interventional
Study Design:
- Treatment
- Non-Randomized
- Open Label
- Single Group Assignment
- Efficacy Study
Conditions:
Interventions:
- Drug: Cyclokapron (tranexamic Acid)
Eligibility
Inclusion Criteria:
all menstruating women regardless of age
Women with heavy periods as measured by pictorial blood assessment chart
Women diagnosed with a bleeding disorder
Exclusion Criteria:
Acquired defective color vision
Factor VIII, Factor IX, FactorXI levels >250%
An inherited thrombophilic defect detected because of a positive family or personal history of thrombosis
Current use of oral contraceptives
- Gender
Female
- Mininum Age
8 Years
- Maximum Age
60 Years
- Healthy Volunteers
No
Resources
Source: Mary M. Gooley Hemophilia Center
Authority: United States: Food and Drug Administration
Locations
-
Mary M. Gooley Hemophilia Center
Rochester
New York
14621
United States
Officials
Peter A Kouides, MD (Principal Investigator, Mary M. Gooley Hemophilia Center)
Sponsors
Mary M. Gooley Hemophilia Center (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- September 1st, 2008
- First Received
- September 18th, 2008
- Last Changed
- September 18th, 2008
Information obtained from ClinicalTrials.gov on October 02, 2008. Link to the current ClinicalTrials.gov record.
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