Back to resultsThe Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
Primary Purpose
vonWillebrand Disease, Hemophilia, Platelet Coagulation Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cyclokapron
Sponsored by
About this trial
This is an interventional treatment trial for vonWillebrand Disease
Eligibility 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
Sites / Locations
- Mary M. Gooley Hemophilia Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TA
Arm Description
on treatment
Outcomes
Primary Outcome Measures
Reduced pictorial blood assessment chart scores from baseline
Secondary Outcome Measures
increased hematocrit
Full Information
NCT ID
NCT00697385
First Posted
June 10, 2008
Last Updated
September 18, 2008
Sponsor
Mary M. Gooley Hemophilia Center
1. Study Identification
Unique Protocol Identification Number
NCT00697385
Brief Title
The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
Official Title
Open Label Continuation Study for the Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mary M. Gooley Hemophilia Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
vonWillebrand Disease, Hemophilia, Platelet Coagulation Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TA
Arm Type
Experimental
Arm Description
on treatment
Intervention Type
Drug
Intervention Name(s)
Cyclokapron
Other Intervention Name(s)
tranexamic Acid
Intervention Description
(2) 500mg tablets taken by mouth every 6-8 hours
Primary Outcome Measure Information:
Title
Reduced pictorial blood assessment chart scores from baseline
Time Frame
3 and 6 months after start of medication
Secondary Outcome Measure Information:
Title
increased hematocrit
Time Frame
3 and 6 months from start of medication
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Kouides, MD
Organizational Affiliation
Mary M. Gooley Hemophilia Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mary M. Gooley Hemophilia Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders
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