Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding

NCT01846507 | Completed Phase 4 Results DMC

• 1 other identifier: NCH12-00822
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

Brief Summary

This is a study to learn more about a drug called Tranexamic acid (TA), otherwise known as Lysteda, and whether or not this drug can decrease menstrual blood loss in young women and lead to an increase in the quality of life. Menorrhagia in young women with bleeding disorders is typically treated with a combination of treatments including hormonal contraceptives. However, there are barriers to hormonal contraception use in younger adolescents. Tranexamic acid is taken orally during the first 5 days of menstrual bleeding. The purposes of this study include: To test the safety and efficacy of Lysteda in adolescent females. To learn how well Lysteda works in decreasing menstrual blood loss. To see if parents and children participating in this study think the drug is improving their quality of life. Lysteda has been approved by the Food and Drug Administration for use in patients \> than 18 years of age but not for younger patients.

Conditions

Heavy Menstrual Bleeding

Keywords

Heavy Menstrual Bleeding; HMB; Lysteda

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Menses for Participant Perceived Blood Loss

  Menorrhagia Impact Questionnaire (MIQ): Question 1 - participant perceived blood loss during most recent menses. Scale ranges from a score of 1 to 4 (with 1 being light blood loss and 4 being very heavy blood loss). Lower values indicate a better outcome (less blood loss during menses). Unit of measure is scores on a scale.

  Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

Secondary Outcomes (6)

• Change From Baseline Menses for Participant Perceived Limitation of School Attendance

  Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

• Change From Baseline Menses for Participant Perceived Limitation in Physical Activities

  Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

• Change From Baseline Menses for Participant Perceived Limitation of Social or Leisure Activities

  Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

• Change From Baseline Menses for Menstrual Blood Loss as Measured by Pictorial Blood Assessment Chart (PBAC) Scores

  Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

• Change From Baseline Menses for Hemoglobin Lab Value

  Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid

Study Arms (1)

Tranexamic acid

EXPERIMENTAL

Subjects will complete a baseline menses (no treatment) followed by 3 menses using tranexamic acid.

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Subjects will be instructed to take 2 tablets (1300) mg of Lysteda three times daily (3900 mg/daily) for five days during monthly menstruation.

Also known as: Lysteda

Tranexamic acid

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Menstruating females 10-19 years of age
• Non-smoker
• Physician and patient have agreed to initiate Lysteda
• Diagnosis of HMB based on the medical judgment of the principal or site investigator
• Subjects must report menstrual periods occurring within 21-60 days from the start of one period to the start of the next menstrual period
• Negative pregnancy test
• Informed consent obtained and signed
• Informed assent obtained and signed
• Understanding of study procedures
• Ability to comply with study procedures for the entire length of the study
• Subjects should be either sexually inactive (abstinent) or agree to use a barrier method with spermicide in the event of sexual activity throughout the study period

You may not qualify if:

• Active thromboembolic disease, history of thromboembolic disease (including retinal vein or artery occlusion), known inherited thrombophilia, or family history of thrombosis in a first degree relative
• Subject has a severe medical or psychiatric illness that, in the opinion of the Investigator, would affect subject safety or compliance
• Clinical evidence of severe bleeding disorder. Patients with mild bleeding disorders such as type 1 von Willebrand disease, mild platelet function defects such as platelet storage pool or release defects, and patients with bleeding due to Ehlers Danlos syndrome WILL be eligible to participate in the study.
• Pregnancy within the past 6 months and/or breast-feeding
• Use of hormonal contraception (estrogen and progestin) within 3 months of study entry, or anticipated need to initiate estrogen-containing hormonal contraception during the study period
• Use of systemic steroids within 1 month of study entry
• History of subarachnoid hemorrhage
• History of Hepatitis B, C, or HIV
• Baseline creatinine \>20% above the upper limit of normal for age
• Severe anemia (hemoglobin \<8 g/dL)
• Systolic blood pressure \<85 or diastolic blood pressure \<55
• Heart rate \<50 at time of screening
• Use of intranasal DDAVP during menses will be permitted, but only if the patient has a history of using DDAVP consistently for ≥3 menstrual cycles prior to study enrollment, so that change in menstrual blood loss due to addition of Lysteda can be assessed. Use of one-time DDAVP during a DDAVP/Stimate challenge is also permitted during the study period, as is use of DDAVP in the event of severe epistaxis, trauma, or surgical procedures during the study period.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (5)

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Akron Children's Hospital

Akron, Ohio, 44302, United States

Location

Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

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

Limitations and Caveats

Small sample size Subjective measurement of menstrual blood loss

Results Point of Contact

• Title: Sarah O'Brien, MD
• Organization: Nationwide Children's Hospital

sarah.obrien@nationwidechildrens.org

614-722-3070

Study Officials

• Sarah O'Brien, MD, MSc

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Experimental Therapeutics

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 24, 2018
• Results First Posted: July 12, 2018

Record last verified: 2018-09

Locations

US (5)