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

Not Applicable

Completed

• Conditions: vonWillebrand Disease; Platelet Coagulation Disorders; Hemophilia
• Interventions: Drug: Cyclokapron

• Registration Number: NCT00697385
• Lead Sponsor: Mary M. Gooley Hemophilia Center

Brief 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.

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 Timeline

• Study Start: 2003-04
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-13
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-18
• Last Update Posted: 2008-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TA	Cyclokapron	on treatment

Primary Outcome Measures

Name	Time	Method
Reduced pictorial blood assessment chart scores from baseline	3 and 6 months after start of medication

Secondary Outcome Measures

Name	Time	Method
increased hematocrit	3 and 6 months from start of medication

Trial Locations

Locations (1)

Mary M. Gooley Hemophilia Center; 🇺🇸 Rochester, New York, United States