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

M

Mary M. Gooley Hemophilia Center

Status

Completed

Conditions

Platelet Coagulation Disorders
vonWillebrand Disease
Hemophilia

Treatments

Drug: Cyclokapron

Study type

Interventional

Funder types

Other

Identifiers

NCT00697385
758-A-03-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

Female

Ages

8 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

TA
Experimental group
Description:
on treatment
Treatment:
Drug: Cyclokapron

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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