An Open-Label, Single-Arm, Efficacy Study of Tranexamic Acid in Adolescents with Heavy Menstrual Bleeding

Sarah H. O'Brien, Surbhi Saini, Heidi Ziegler, Myra Christian-Rancy, Sanjay Ahuja, Kerry Hege, Stephanie L. Savelli, Sara K. Vesely

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Study Objective: Heavy menstrual bleeding (HMB) occurs in up to 40% of adolescent girls, significantly affecting their daily activities. Identifying alternative treatment strategies for HMB is particularly important for adolescents who prefer not to take hormonal contraception. Our objective was to determine whether use of tranexamic acid (TA) would increase health-related quality of life and decrease menstrual blood loss (MBL) in adolescents with HMB. Design, Setting, Participants, Interventions, and Main Outcome Measures: In an open-label, multi-institutional, single-arm, efficacy study, patients 18 years of age or younger with HMB were treated with oral TA 1300 mg 3 times daily during the first 5 days of menses and monitored over the course of 4 menstrual cycles (1 baseline; 3 treatment cycles). Assessment of MBL was performed using the Menorrhagia Impact Questionnaire (MIQ) and the Pictorial Blood Assessment Chart. The MIQ includes Likert scale items, validated to assess the influence of HMB on quality of life. In previous studies, a 1-point decrease or more in score correlated with clinically significant improvement. Results: Thirty-two patients enrolled in the study, and 25 had sufficient follow-up data to be deemed evaluable. The mean age of the participants was 14.7 years (range, 11-18 years). There was an overall improvement in all items of the MIQ, with a greater than 1-point improvement in the MIQ perceived blood loss scale. When using TA, mean Pictorial Blood Assessment Chart score improved by 100 points. There were no medication-related serious adverse events. Conclusion: Use of TA in female adolescents with HMB is well tolerated and leads to clinically meaningful reduction in MBL.

Original languageEnglish (US)
Pages (from-to)305-311
Number of pages7
JournalJournal of Pediatric and Adolescent Gynecology
Volume32
Issue number3
DOIs
StatePublished - Jun 1 2019

Fingerprint

Tranexamic Acid
Menorrhagia
Hemorrhage
Quality of Life
Menstruation
Menstrual Cycle
Contraception
Outcome Assessment (Health Care)
Surveys and Questionnaires
Therapeutics

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynecology

Cite this

O'Brien, Sarah H. ; Saini, Surbhi ; Ziegler, Heidi ; Christian-Rancy, Myra ; Ahuja, Sanjay ; Hege, Kerry ; Savelli, Stephanie L. ; Vesely, Sara K. / An Open-Label, Single-Arm, Efficacy Study of Tranexamic Acid in Adolescents with Heavy Menstrual Bleeding. In: Journal of Pediatric and Adolescent Gynecology. 2019 ; Vol. 32, No. 3. pp. 305-311.
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O'Brien, SH, Saini, S, Ziegler, H, Christian-Rancy, M, Ahuja, S, Hege, K, Savelli, SL & Vesely, SK 2019, 'An Open-Label, Single-Arm, Efficacy Study of Tranexamic Acid in Adolescents with Heavy Menstrual Bleeding', Journal of Pediatric and Adolescent Gynecology, vol. 32, no. 3, pp. 305-311. https://doi.org/10.1016/j.jpag.2019.01.009

An Open-Label, Single-Arm, Efficacy Study of Tranexamic Acid in Adolescents with Heavy Menstrual Bleeding. / O'Brien, Sarah H.; Saini, Surbhi; Ziegler, Heidi; Christian-Rancy, Myra; Ahuja, Sanjay; Hege, Kerry; Savelli, Stephanie L.; Vesely, Sara K.

In: Journal of Pediatric and Adolescent Gynecology, Vol. 32, No. 3, 01.06.2019, p. 305-311.

Research output: Contribution to journalArticle

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T1 - An Open-Label, Single-Arm, Efficacy Study of Tranexamic Acid in Adolescents with Heavy Menstrual Bleeding

AU - O'Brien, Sarah H.

AU - Saini, Surbhi

AU - Ziegler, Heidi

AU - Christian-Rancy, Myra

AU - Ahuja, Sanjay

AU - Hege, Kerry

AU - Savelli, Stephanie L.

AU - Vesely, Sara K.

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N2 - Study Objective: Heavy menstrual bleeding (HMB) occurs in up to 40% of adolescent girls, significantly affecting their daily activities. Identifying alternative treatment strategies for HMB is particularly important for adolescents who prefer not to take hormonal contraception. Our objective was to determine whether use of tranexamic acid (TA) would increase health-related quality of life and decrease menstrual blood loss (MBL) in adolescents with HMB. Design, Setting, Participants, Interventions, and Main Outcome Measures: In an open-label, multi-institutional, single-arm, efficacy study, patients 18 years of age or younger with HMB were treated with oral TA 1300 mg 3 times daily during the first 5 days of menses and monitored over the course of 4 menstrual cycles (1 baseline; 3 treatment cycles). Assessment of MBL was performed using the Menorrhagia Impact Questionnaire (MIQ) and the Pictorial Blood Assessment Chart. The MIQ includes Likert scale items, validated to assess the influence of HMB on quality of life. In previous studies, a 1-point decrease or more in score correlated with clinically significant improvement. Results: Thirty-two patients enrolled in the study, and 25 had sufficient follow-up data to be deemed evaluable. The mean age of the participants was 14.7 years (range, 11-18 years). There was an overall improvement in all items of the MIQ, with a greater than 1-point improvement in the MIQ perceived blood loss scale. When using TA, mean Pictorial Blood Assessment Chart score improved by 100 points. There were no medication-related serious adverse events. Conclusion: Use of TA in female adolescents with HMB is well tolerated and leads to clinically meaningful reduction in MBL.

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