Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
Menorrhagia, considered a public health challenge and reported by 5 to 10% of adult women, is
encountered even more frequently in adolescents. Surveys of school students in the United
States (US) and Europe reported menorrhagia in 37% to 55% of adolescent females. Medical
management of adolescent menorrhagia includes various formulations of hormonal therapy and
the antifibrinolytic agent epsilon aminocaproic acid. Oral tranexamic acid (TA), a more
potent antifibrinolytic agent used as standard therapy for menorrhagia in adult women and in
adolescent women in Europe and Canada, was not previously available in the US. Subsequent to
US FDA approval in November 2009 of a novel oral TA formulation to treat cyclic heavy
menstrual bleeding in adult women, this medication is currently included in the treatment
armamentarium for adult menorrhagia. There is currently no preliminary data available in the
US about the clinical use of oral TA in an exclusive adolescent population with menorrhagia.
Oral contraceptive pills (OCP) are considered standard therapy in the management of
menorrhagia in teen-aged women. Oral TA has been shown to be more efficacious than
progesterone-only hormonal therapy for menorrhagia in adult women. However, there is no data
available comparing the efficacy of oral TA and combined OCP (COCP) in adult women or in
adolescents with menorrhagia.
The study hypothesis is that, in adolescent menorrhagia, oral TA will have comparable
efficacy in reducing menstrual blood loss (MBL) and improving quality of life (QOL) when
compared to the commonly prescribed COCP.
This hypothesis was tested by comparing the efficacy of these two medications, in a
prospective randomized crossover trial in post-menarchal young girls with menorrhagia.