Trial | NCT00697385  Report issue

Title

The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
Open Label Continuation Study for the Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    13
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.
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.
Study Started
Apr 30
2003
Primary Completion
Jun 30
2008
Study Completion
Jun 30
2008
Last Update
Sep 19
2008
Estimate

Drug Cyclokapron

(2) 500mg tablets taken by mouth every 6-8 hours

  • Other names: tranexamic Acid

TA Experimental

on treatment

Criteria 

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
No Results Posted