Safety after extended repeated use of ulipristal acetate for uterine fibroids.

ABSTRACT:

Objective

To assess long term safety of extended repeated 3-month courses of ulipristal acetate (UPA) 10 mg/day, for up to 8 courses, with focus on endometrial and laboratory safety parameters.

Methods

This long-term, multi-center, open-label cohort, follow up study consisted of up to 8 consecutive 3-month courses of daily UPA 10 mg, each separated by a drug free period of 2 spontaneous menstrual bleeds. Sixty-four pre-menopausal women, with moderate to severe symptomatic uterine myoma(s) and heavy bleeding were enrolled and were studied for approximately 4 years. The main outcome measures were endometrial histology, laboratory parameters and general safety.

Results

All data was reported in a descriptive manner with no formal statistical comparisons. In the 64 women,

SUBMITTER: Fauser BC 

PROVIDER: S-EPMC5340384 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature