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

September 18, 2008 updated by: Mary M. Gooley Hemophilia Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TA
on treatment
Drug: Cyclokapron
(2) 500mg tablets taken by mouth every 6-8 hours
Other Names:
  • tranexamic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduced pictorial blood assessment chart scores from baseline
Time Frame: 3 and 6 months after start of medication
3 and 6 months after start of medication

Secondary Outcome Measures

Outcome Measure
Time Frame
increased hematocrit
Time Frame: 3 and 6 months from start of medication
3 and 6 months from start of medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mary M. Gooley Hemophilia Center

Investigators

  • Principal Investigator: Peter A Kouides, MD, Mary M. Gooley Hemophilia Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 10, 2008

First Submitted That Met QC Criteria

June 11, 2008

First Posted (Estimate)

June 13, 2008

Study Record Updates

Last Update Posted (Estimate)

September 19, 2008

Last Update Submitted That Met QC Criteria

September 18, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 758-A-03-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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