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The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00697385
First Posted: June 13, 2008
Last Update Posted: September 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mary M. Gooley Hemophilia Center
June 10, 2008
June 13, 2008
September 19, 2008
April 2003
June 2008   (Final data collection date for primary outcome measure)
Reduced pictorial blood assessment chart scores from baseline [ Time Frame: 3 and 6 months after start of medication ]
Same as current
Complete list of historical versions of study NCT00697385 on ClinicalTrials.gov Archive Site
increased hematocrit [ Time Frame: 3 and 6 months from start of medication ]
Same as current
Not Provided
Not Provided
 
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
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • vonWillebrand Disease
  • Hemophilia
  • Platelet Coagulation Disorders
Drug: Cyclokapron
(2) 500mg tablets taken by mouth every 6-8 hours
Other Name: tranexamic Acid
Experimental: TA
on treatment
Intervention: Drug: Cyclokapron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
8 Years to 60 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00697385
758-A-03-1
No
Not Provided
Not Provided
Peter A. kouides, M.D., Mary M. Gooley Hemophilia Center
Mary M. Gooley Hemophilia Center
Not Provided
Principal Investigator: Peter A Kouides, MD Mary M. Gooley Hemophilia Center
Mary M. Gooley Hemophilia Center
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP