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Womens Health (Lond Engl). 2011 Sep;7(5):591-8. doi: 10.2217/whe.11.55.

Safety of tranexamic acid in women with heavy menstrual bleeding: an open-label extension study.

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  • 1Carolina Women's Research & Wellness Center, Durham, NC 27713, USA. andrealukes@cwrwc.com

Abstract

AIMS:

An open-label, extension clinical study was conducted to assess the safety of a novel, oral formulation of tranexamic acid (TA) in women with cyclic heavy menstrual bleeding.

PATIENTS & METHODS:

Eligible patients who completed either a three- or six-cycle double-blinded clinical trial of TA were offered enrollment into a study of nine cycles with TA (1.3 g orally three times/day for a maximum of 5 days per cycle). Safety was assessed by the incidence of treatment-emergent adverse events, ophthalmologic examinations and ECGs, among other evaluations.

RESULTS:

The most commonly reported treatment-emergent adverse events were menstrual discomfort (46.2%), headache (43.9%) and back pain (23.1%). A small proportion of participants (3.8%) reported ocular adverse events, but there was no evidence of ocular toxicity. No prothrombotic effects were observed.

CONCLUSION:

During nine menstrual cycles of treatment, this novel formulation of TA was well tolerated and exhibited a favorable safety profile supporting its use as a therapy for cyclic heavy menstrual bleeding.

PMID:
21879827
[PubMed - indexed for MEDLINE]
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