The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders - Full Text View

Sponsored by:	Mary M. Gooley Hemophilia Center
Information provided by:	Mary M. Gooley Hemophilia Center
ClinicalTrials.gov Identifier:	NCT00697385

Purpose

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.

Condition	Intervention
vonWillebrand Disease Hemophilia Platelet Coagulation Disorders	Drug: Cyclokapron

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Bleeding Disorders

Drug Information available for: Tranexamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Open Label Continuation Study for the Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders

Further study details as provided by Mary M. Gooley Hemophilia Center:

Primary Outcome Measures:

Reduced pictorial blood assessment chart scores from baseline [ Time Frame: 3 and 6 months after start of medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

increased hematocrit [ Time Frame: 3 and 6 months from start of medication ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	April 2003
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TA: Experimental on treatment	Drug: Cyclokapron (2) 500mg tablets taken by mouth every 6-8 hours

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.

Eligibility

Ages Eligible for Study:	8 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697385

Locations

United States, New York
Mary M. Gooley Hemophilia Center
Rochester, New York, United States, 14621

Sponsors and Collaborators

Mary M. Gooley Hemophilia Center

Investigators

Principal Investigator:

Peter A Kouides, MD

Mary M. Gooley Hemophilia Center

More Information

Responsible Party:	Mary M. Gooley Hemophilia Center ( Peter A. kouides, M.D. )
Study ID Numbers:	758-A-03-1
Study First Received:	June 10, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00697385
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antiplasmin
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Coagulation Disorders

Hemophilia A
Vascular Diseases
Tranexamic Acid
Hemorrhage
Hemostatic Disorders

Additional relevant MeSH terms:

Disease
Molecular Mechanisms of Pharmacological Action
Coagulants
Coagulation Protein Disorders
Hematologic Agents
Pharmacologic Actions
Hemostatics

Fibrin Modulating Agents
Pathologic Processes
Blood Coagulation Disorders, Inherited
Antifibrinolytic Agents
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009