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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Capital District Health Authority, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Canadian Hemophilia Society
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00904709
First received: May 15, 2009
Last updated: May 19, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Menorrhagia
Drug: tranexamic acid
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Minimal effective dose of tranexamic acid [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life Assessment [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 149
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: K. Sue Robinson, QE II HSC
ClinicalTrials.gov Identifier: NCT00904709     History of Changes
Other Study ID Numbers: CDHA-RS/2009-341
Study First Received: May 15, 2009
Last Updated: May 19, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Menorrhagia
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014