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

NCT ID: NCT00697385

Last Updated: 2008-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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vonWillebrand Disease Hemophilia Platelet Coagulation Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TA

on treatment

Group Type EXPERIMENTAL

Cyclokapron

Intervention Type DRUG

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

Interventions

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Cyclokapron

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

Intervention Type DRUG

Other Intervention Names

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tranexamic Acid

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mary M. Gooley Hemophilia Center

OTHER

Sponsor Role lead

Responsible Party

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Mary M. Gooley Hemophilia Center

Principal Investigators

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Peter A Kouides, MD

Role: PRINCIPAL_INVESTIGATOR

Mary M. Gooley Hemophilia Center

Locations

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Mary M. Gooley Hemophilia Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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758-A-03-1

Identifier Type: -

Identifier Source: org_study_id