NCT00697385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
Last Updated

September 19, 2008

Status Verified

September 1, 2008

Enrollment Period

5.2 years

First QC Date

June 10, 2008

Last Update Submit

September 18, 2008

Conditions

vonWillebrand DiseaseHemophiliaPlatelet Coagulation Disorders

Outcome Measures

Primary Outcomes (1)

  • Reduced pictorial blood assessment chart scores from baseline

    3 and 6 months after start of medication

Secondary Outcomes (1)

  • increased hematocrit

    3 and 6 months from start of medication

Study Arms (1)

TA

EXPERIMENTAL

on treatment

Drug: Cyclokapron

Interventions

CyclokapronDRUG

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

Also known as: tranexamic Acid
TA

Eligibility Criteria

Age8 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • all menstruating women regardless of age
  • Women with heavy periods as measured by pictorial blood assessment chart
  • Women diagnosed with a bleeding disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mary M. Gooley Hemophilia Center

Rochester, New York, 14621, United States

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Peter A Kouides, MD

    Mary M. Gooley Hemophilia Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 13, 2008

Study Start

April 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 19, 2008

Record last verified: 2008-09

Locations

US(1)