We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • increased hematocrit [ Time Frame: 3 and 6 months from start of medication ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 60 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: 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
First Submitted: June 10, 2008
First Posted: June 13, 2008
Last Update Posted: September 19, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Disease
Von Willebrand Diseases
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Coagulation Protein Disorders
Blood Platelet Disorders
Genetic Diseases, Inborn
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants