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

NCT00904709 | Completed Phase 4

• 1 other identifier: CDHA-RS/2009-341
• Study Type: interventional
• Target: 249
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menorrhagia

Outcome Measures

Primary Outcomes (1)

• Minimal effective dose of tranexamic acid

  4 months

Secondary Outcomes (1)

• Quality of Life Assessment

  4 months

Study Arms (1)

Tranexamic acid, Menorrhagia, Bleeding

EXPERIMENTAL

Tranexamic acid with titrated doses. All women with menorrhagia will take .

Drug: tranexamic acid

Interventions

tranexamic acid DRUG

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.

Also known as: Cyklokapron

Tranexamic acid, Menorrhagia, Bleeding

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Must be able to swallow tablets

You may not qualify if:

• Endometrial abnormality
• Pelvic infection
• Pregnancy
• Breast Feeding
• Requirement for birth control
• Known intolerance/lack of effect of tranexamic acid

Sponsors & Collaborators

• K. Sue Robinson: lead
• Canadian Hemophilia Society: collaborator

MeSH Terms

Conditions

Menorrhagia

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: hematologist

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 20, 2009
• Study Start: October 19, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 18, 2018

Record last verified: 2018-07