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

Hemophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697385
• Other study ID #: 758-A-03-1
• Status: Completed
• Phase: N/A
• First received: June 10, 2008
• Last updated: September 18, 2008
• Start date: April 2003
• Est. completion date: June 2008

Study information

• Verified date: September 2008
• Source: Mary M. Gooley Hemophilia Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 8 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemophilia
• Hemostatic Disorders
• Platelet Coagulation Disorders
• Von Willebrand Diseases
• vonWillebrand Disease

Intervention

Drug:
• Cyclokapron
(2) 500mg tablets taken by mouth every 6-8 hours

Locations

Country	Name	City	State
United States	Mary M. Gooley Hemophilia Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Mary M. Gooley Hemophilia Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced pictorial blood assessment chart scores from baseline		3 and 6 months after start of medication	No
Secondary	increased hematocrit		3 and 6 months from start of medication	No