Tranexamic Acid vs Oral Contraceptive Pilot Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Texas Children's Hospital
Information provided by (Responsible Party):
Lakshmi Srivaths, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01428713
First received: September 1, 2011
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

Menorrhagia (heavy menstrual bleeding or heavy bleeding during your "period") is a common problem in adolescents. It results in major quality of life issues such as loss of school days, and reduction in social activities and travel. Menorrhagia also occurs in adult women. There is some data regarding menorrhagia in adult women but there has been limited research in this area in adolescents. As a result, most of the treatments for adolescents with menorrhagia are based on experience in adult women.

This study is specifically designed to help gather information about how to better diagnose and treat menorrhagia in adolescent girls. This study will compare treatment with Tranexamic Acid (TA) to treatment with combined oral contraceptives. Both of these treatments are currently used to treat menorrhagia in adult women.

Tranexamic acid is approved for such treatment in adult women but not in adolescent women. Oral TA, not available previously in the U.S., was approved by the United States Food and Drug Administration in November 2009 for management of heavy menstrual bleeding in women. There is currently no approved indication for the use of tranexamic acid in patients less than 18 years of age. The use of oral contraceptives in adolescent women is considered standard of care.

The main purpose of this study is to find out if oral tranexamic acid is as good as or better than combined oral contraceptives in reducing menstrual blood loss in adolescents with menorrhagia.

The second purpose is to find out if oral tranexamic acid is as good as or better than combined oral contraceptives in improving quality of life in adolescents with menorrhagia.


Condition Intervention
Menorrhagia
Drug: Oral tranexamic acid
Drug: Oral Contraceptive Pills

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Crossover Trial of Oral Tranexamic Acid and Combined Oral Contraceptive in Adolescents With Menorrhagia - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Compare Efficacy of Oral TA to Combined Oral Contraceptives [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    To compare the efficacy of oral TA to combined oral contraceptives in reducing menstrual blood loss in adolescents with menorrhagia.


Secondary Outcome Measures:
  • Compare Quality of Life Improvement [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    To compare the ability of oral tranexamic acid to combined oral contraceptive in improving quality of life in adolescents with menorrhagia.


Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A-Oral tranexamic acid
Group A will receive oral tranexamic acid at 1300 mg (two 650mg tablets), three times each day on days 1 to 5 of menstrual cycle for 3 cycles.
Drug: Oral tranexamic acid
Group A will receive oral tranexamic acid at 1300 mg (two 650mg tablets), three times each day on days 1 to 5 of menstrual cycle for 3 cycles.
Active Comparator: Group B-Combined oral contraceptive pills
Group B will receive combined oral contraceptive pills with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles.
Drug: Oral Contraceptive Pills
Group B will receive combined oral contraceptive pills with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles.

Detailed Description:

Subjects will be randomized to one of two groups (group A or B).

Group A will receive oral tranexamic acid at 1300 mg (two 650mg tablets), three times each day on days 1 to 5 of menstrual cycle for 3 cycles.

Group B will receive combined oral contraceptive pills (OCP) with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles.

After 3 cycles of therapy, both groups will have one cycle without any therapy. Then, the groups will cross over. Group A, who first received TA, will then receive OCP. Group B, who first received OCP, will then receive TA.

All subjects will receive both tranexamic acid and oral contraceptive pills.

There will be a total of 3 study-associated visits per patient: 1 at baseline and 2 at the end of 3 cycles on each medication. These visits are considered within standard of care, as subjects with menorrhagia have frequent monitoring until the effectiveness of the treatment is determined.

At the study visits the following will be done:

  1. Assessment of the last menstrual period (amount of blood lost) and the number of days the period lasted
  2. Quality of Life evaluation - you will complete a standardized quality of life questionnaire
  3. Detailed history and physical examination to evaluate for drug side effects and to look for signs of blood clots. If the doctor thinks the subject may have a blood clot, they may need an ultrasound to look for a blood clot.
  4. Blood will be drawn for a complete blood count test. This is a standard test that would be done even if you were not on this study.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Menstruating females with menorrhagia or menometrorrhagia referred to hematology or gynecology clinics at Texas Childrens Hospital. Menorrhagia is defined as regular periods with heavy menstrual bleeding with a PBAC score greater than 100; menometrorrhagia is heavy vaginal bleeding occurring at irregular intervals.
  2. PBAC Score greater than 100 for 2 consecutive cycles
  3. Pelvic ultrasound that excludes pelvic pathology that can cause menorrhagia within 12 months prior to study participation.
  4. Normal external genitalia examination within 6 months prior to study participation.
  5. Normal TSH in the last 6 months prior to study participation.
  6. Negative urine or serum pregnancy test within 4 weeks prior to study participation.

Exclusion Criteria:

  1. Presence of intra uterine device.
  2. Presence of a diagnosed bleeding disorder based on the standard work-up including complete blood count (CBC), prothrombin time, partial thromboplastin time, fibrinogen, von Willebrand panel and platelet function analysis (PFA-100) or platelet aggregation.
  3. Intake of medications with increased risk of bleeding
  4. Taking herbal products.
  5. Sexually active status.
  6. Body weight less than 40 kg.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428713

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Texas Children's Hospital
  More Information

No publications provided

Responsible Party: Lakshmi Srivaths, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01428713     History of Changes
Other Study ID Numbers: H-27934-TA vs OCP Study
Study First Received: September 1, 2011
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
menorrhagia
oral contraceptives
oral tranexamic acid

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Tranexamic Acid
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on July 20, 2014