COLUMBIA LABS' TRIAL IN PREVENTING PRETERM BIRTH MISSES ENDPOINTS

Columbia Laboratories announced that its Phase III clinical trial of progesterone for the prevention of preterm birth for women with a previous preterm birth earlier than 35 weeks of gestation did not meet its primary endpoint, a reduction in the incidence of preterm birth at week 32, or secondary endpoints, a reduction at weeks 28, 35 and 37.

Of the 611 patients in this randomized, placebo-controlled, double-blind clinical trial, 302 received placebo and 309 received Prochieve (progesterone gel) 8 percent. The mean gestational age at delivery was approximately 37 weeks in both the active and placebo groups, an improvement over a mean of 30 weeks in the previous preterm birth for both groups. More than 60 percent of patients had a previous preterm birth at or before 32 weeks gestation.

"These study results are extremely disappointing. Despite solid evidence in this and other studies that Prochieve 8 percent 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," Robert Mills, president and CEO of Columbia Labs, said.

Prochieve is currently approved for progesterone supplementation or replacement as part of assisted reproductive technology treatment of infertile women with progesterone deficiency and for the treatment of secondary amenorrhea.