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

This study has been completed.
Sponsor:
Information provided by:
Mary M. Gooley Hemophilia Center
ClinicalTrials.gov Identifier:
NCT00697385
First received: June 10, 2008
Last updated: September 18, 2008
Last verified: September 2008
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Continuation Study for the Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders

Resource links provided by NLM:


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
Experimental: TA
on treatment
Drug: Cyclokapron
(2) 500mg tablets taken by mouth every 6-8 hours
Other Name: tranexamic Acid

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

No publications provided

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

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia A
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014