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The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders

NCT00904709 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2018-07-18

No results posted yet for this study

Summary

Many women have heavy periods and this can be associated with low blood, tiredness and inability to carry out normal activities. Approximately 10-30% of these women will have an underlying bleeding disorder. There is a drug called tranexamic acid which is commonly used and is effective in reducing menstrual flow. However, up to 1/3 of women have side effects and they are more common at higher doses. In the medical literature, there are different dosing schedules and there is one commonly recommended in Canada. Women with underlying bleeding disorders may require higher doses of this medication compared to those who do not. In this study, the investigators want to find the lowest effective dose of tranexamic acid for girls and women with heavy periods who have bleeding disorders and the investigators think this will be lower then the usual recommended dose. If the investigators' results support this, it may contribute to changing how the investigators presently prescribe this medication and may provide a better option for women with heavy periods in particular those with bleeding disorders. The investigators have just started a Women with Bleeding Disorders Clinic and hope that this project will lead to better care for the patients and more research in the future.

Conditions

  • Menorrhagia

Interventions

DRUG

tranexamic acid

After The starting dose of tranexamic acid will be 500 mg twice daily beginning the first day of menstrual flow for a total of 6 days per menstrual cycle. If after 2 days there is still menorrhagia without significant side effects the will be increased. The women will be assessed again at day 4 and 9 and dose escalation will continue until they have reached the optimal dose.The dose of tranexamic acid will be increased as follows: 1000 mg twice daily, 1000 mg three times daily, 1500 mg/1000 mg/1000 mg, 1000 mg four times daily, 1500 mg three times daily, and 1500 mg four times daily (maximum dose).Each patient will be followed for a minimum of one menstrual cycle and a maximum of 3 cycles.

Sponsors & Collaborators

  • Canadian Hemophilia Society

    collaborator OTHER

  • K. Sue Robinson

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-19
Primary Completion
2014-03-01
Completion
2014-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00904709 on ClinicalTrials.gov