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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00904709
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : July 18, 2018
Canadian Hemophilia Society
Information provided by (Responsible Party):
K. Sue Robinson, Nova Scotia Health Authority

Brief 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.

Condition or disease Intervention/treatment Phase
Menorrhagia Drug: tranexamic acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Assessment of the Minimal Effective and Tolerated Dose of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders
Actual Study Start Date : October 19, 2009
Actual Primary Completion Date : March 1, 2014
Actual Study Completion Date : March 1, 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tranexamic acid, Menorrhagia, Bleeding
Tranexamic acid with titrated doses. All women with menorrhagia will take .
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.
Other Name: Cyklokapron

Primary Outcome Measures :
  1. Minimal effective dose of tranexamic acid [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Quality of Life Assessment [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:Clinical diagnosis of Menorrhagia

  • Must be able to swallow tablets

Exclusion Criteria:

  • Endometrial abnormality
  • Pelvic infection
  • Pregnancy
  • Breast Feeding
  • Requirement for birth control
  • Known intolerance/lack of effect of tranexamic acid
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Responsible Party: K. Sue Robinson, hematologist, Nova Scotia Health Authority Identifier: NCT00904709    
Other Study ID Numbers: CDHA-RS/2009-341
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Uterine Hemorrhage
Uterine Diseases
Menstruation Disturbances
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action