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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00697385

Enrollment

Registered

2008-06-13

Start date

2003-04-30

Completion date

2008-06-30

Last updated

2008-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia, Platelet Coagulation Disorders, vonWillebrand Disease

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.

Interventions

DRUGCyclokapron

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

8 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
increased hematocrit	3 and 6 months from start of medication

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026