The study was a Phase 2, double-blind study of oral Proellex® (telapristone acetate) in a population of women with moderate to severe confirmed endometriosis defined as a baseline BBSS Score (Biberoglu and Behrman Symptom Score) of 7 or greater. Subjects were randomized to 6 or 12 mg of Proellex® or placebo in a 1:1:1 fashion. A course of treatment lasted 18 weeks and was followed by an Off Drug Interval. Subjects kept daily diaries recording assessments of pain, menstrual bleeding and analgesic use.
The study randomized 60 subjects, 13 in
Subjects assessed menstrual and non-menstrual pain daily during baseline and treatment. The median percentage change from baseline in the patient BBSS assessment of menstrual pain showed that subjects improved with an 85.4% reduction in baseline score (p < 0.0001). In addition, despite evidence of a placebo response, subjects treated with Proellex® had a statistically significant greater reduction in menstrual pain compared to the 37.5% change from baseline achieved with placebo (p = 0.0008). Although non-menstrual pelvic pain was also reduced with treatment, a difference between treatment groups could not be detected.
Encouragingly, the improvement in menstrual pain translated to a reduction in the use of analgesics. During this first course of treatment, subjects treated with Proellex® experienced a 56% reduction in total pill count while placebo-treated subjects' pill use declined by 30% (p = 0.0521). The reduction in non-prescription use was most striking: Proellex®-treated subjects had a 74% reduction while placebo-treated subjects only experienced a reduction of 11% (p = 0.0423).
Treatment with Proellex® was generally well tolerated.
Given these results, the Company is preparing to interact with the
About Repros Therapeutics Inc.®
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as "may," "will," "expect," "anticipate," "continue," "estimate," "project," "intend," "believe," "plan," "seek," "could," "can," "should" or similar expressions. These statements are based on assumptions that the Company has made in light of the Company's experience in the industry, as well as the Company's
perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to the timing and nature of the results of clinical studies and the impact of such results. Such statements are based on current expectations that involve a number of known and unknown risks, uncertainties and other factors that may cause actual events to be materially different from those expressed or implied by such forward-looking statements, including risks that additional phases of clinical studies may not be successfully undertaken or completed, that the
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