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news.Columbia Laboratories has completed enrollment in its placebo-controlled phase III study of Prochieve 8% for the prevention of preterm birth.
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The prevention of preterm birth would be a new indication for Prochieve which is currently approved and commercially available to treat infertility and secondary amenorrhea.
This large-scale global trial involves over 600 patients at more than 60 centers throughout the US, Europe, South America, Asia and South Africa. It is designed to assess the ability of Prochieve to safely, effectively and tolerably prevent preterm birth in pregnant women who are predisposed to this problem.
“We look forward to announcing initial results from this study in late first quarter or early second quarter 2007. Assuming positive results, we will compile and submit the dossier for a label indication with the FDA in mid-2007,” said Robert Mills, Columbia’s president and CEO.