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CompletedNCT00697385Updated Sep 19, 2008

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

An interventional study of Cyclokapron in vonWillebrand Disease, Hemophilia and Platelet Coagulation Disorders, sponsored by Mary M. Gooley Hemophilia Center. Completed at 1 site in United States. Open to female participants aged 8 Years to 60 Years. Per ClinicalTrials.gov, last updated 2008-09-19.

Sponsored by Mary M. Gooley Hemophilia Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
8 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • vonWillebrand Disease
  • Hemophilia
  • Platelet Coagulation Disorders

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03

In context

Hemophilia A

885 studies on the registry are indexed under Hemophilia A; 139 are open to participants now.

This study's enrollment of 13 is below the median of 27 across 523 interventional studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

This is the only study on the registry with Mary M. Gooley Hemophilia Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    TA

    on treatment

    Drug: Cyclokapron

Interventions

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

    Also known as: tranexamic Acid

06

What researchers measure

Primary outcomes

  1. Reduced pictorial blood assessment chart scores from baseline

    Time frame: 3 and 6 months after start of medication

Secondary outcomes

  1. increased hematocrit

    Time frame: 3 and 6 months from start of medication

07

Study locations

1 site
  • Mary M. Gooley Hemophilia Center
    Rochester, New York 14621, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2003, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2008
First posted
Jun 13, 2008
Start
Apr 2003
Primary completionActual
Jun 2008
CompletionActual
Jun 2008
Last update
Sep 19, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00697385
Lead sponsor
Mary M. Gooley Hemophilia Center
First posted
Jun 13, 2008
Start date
Apr 2003
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Sep 19, 2008

Study contacts

Peter A Kouides, MD
principal investigator · Mary M. Gooley Hemophilia Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tranexamic Acid

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