Columbia Laboratories’ progesterone gel for the prevention of preterm birth in women with a previous preterm birth earlier than 35-weeks gestation failed in its Phase III trial. Prochieve did not achieve any reduction in the incidence of preterm birth at week 32, the primary endpoint, or at weeks 28, 35, and 37, secondary endpoints of the study.
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"These study results are extremely disappointing. Despite solid evidence in this and other studies that Prochieve 8% effectively delivers progesterone to the uterus, there was no difference in the reduction of preterm birth incidence in patients with a previous preterm birth earlier than 35 weeks and treated with progesterone versus placebo at any endpoint," says Robert S. Mills, president and CEO of Columbia Laboratories.
Of the 611 evaluable patients in this randomized, placebo-controlled, double-blind study, 302 received placebo and 309 received Prochieve 8%. The mean gestational age at delivery was approximately 37 weeks in both the active and placebo groups. This was an improvement from a mean of 30 weeks in the previous preterm birth for both groups. Over 60% of evaluable patients had a previous preterm birth at or below 32 weeks gestation.