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Multicenter phase II study: investigational drug treats fibroid-related bleeding.(News)
HOUSTON -- The investigational selective progesterone receptor modulator asoprisnil induced amenorrhea or normal menstrual periods in a clear majority of women with myoma-associated menorrhagia in a multicenter phase II study.
"In subjects with uterine fibroids, asoprisnil rapidly suppressed both the duration and intensity of uterine bleeding without inducing unscheduled bleeding," Dr. Kristof Chwalisz reported during the annual meeting of the Society for Gynecologic Investigation.
"Hemoglobin [concentrations] increased significantly at all treatment doses," stated Dr. Chwalisz, a research scientist for TAP Pharmaceutical Products, Lake Forest, Ill., which sponsored the study.
Asoprisnil, formerly known as J867, is currently in yearlong, phase III trials and holds the promise of becoming the first medical treatment approved for uterine fibroids.
Phase II trial results that were released a year ago demonstrated a reduction in both symptoms and uterine fibroid size.
Bleeding patterns and hemoglobin levels were the focus of a more recent analysis of the phase II, randomized, double-blind, placebo-controlled, parallel group study.
In this analysis, bleeding diaries kept over the course of 3 months showed a "dramatic," dose-dependent reduction in spotting and bleeding among 129 women aged 18-49 who had large ([greater than or equal to] 3 cm) symptomatic uterine fibroids.
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Source: HighBeam Research, Multicenter phase II study: investigational drug treats...