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Completed

NCT Number: NCT00697385

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.

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Key information

Conditions

vonWillebrand Disease Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia Hemophilia A Hemorrhagic Disorders Platelet Coagulation Disorders

Age range

8 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mary M. Gooley Hemophilia Center

Rochester, New York, 14621, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclokapron

Drug

(2) 500mg tablets taken by mouth every 6-8 hours

Other names: tranexamic Acid

Primary outcomes

  1. Reduced pictorial blood assessment chart scores from baseline

    Time frame: 3 and 6 months after start of medication

Secondary outcomes

  1. increased hematocrit

    Time frame: 3 and 6 months from start of medication

Sponsors and collaborators

Lead sponsor

Mary M. Gooley Hemophilia Center

Other

Registry information

Official study title

Open Label Continuation Study for the Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jun 13, 2008
Registry last updated
Sep 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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