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Vaginal progesterone gel may improve infant outcomes and...
Date:10/2/2007

LIVINGSTON, NJ October 2, 2007 For the first time, data show a positive association between the use of vaginal progesterone and infants overall health at birth. Babies born to women with high-risk pregnancies treated with PROCHIEVE 8% (progesterone gel) appear to be less likely to need intensive care than babies born to mothers treated with placebo, Columbia Laboratories, Inc. (NASDAQ:CBRX) announced today. The data are published in the October issue of Ultrasound in Obstetrics & Gynecology (also known as The White Journal), the official publication of the International Society of Ultrasound in Obstetrics and Gynecology.

Researchers conducted a secondary analysis of phase III data from the largest-ever singleton preterm birth prevention study with progesterone looking specifically at a group of 46 women with high-risk pregnancies because they had a short cervix (less than 2.8 cm measured by trans-vaginal ultrasound). This analysis shows several statistically significant findings, including:

  • Only one out of six (16%) newborns of mothers treated with vaginal progesterone gel needed to be admitted to neonatal intensive care units compared to one out of two (52%) newborns of mothers treated with placebo (p-value of 0.016); and

  • Infants born to mothers treated with vaginal progesterone gel who were admitted to intensive care units spent on average only one day in intensive care compared to more than two weeks for those babies of mothers who received placebo (p-value of 0.013).

This is the first and only preterm birth prevention study that is associated with statistically significant improvements in clinically important measures of infant outcomes. Additional studies are being planned to repeat this unique finding.

In addition, the analysis provided new insight into which women with high-risk pregnancies respond to treatment with vaginal progesterone gel. It showed that treatment with vaginal pr
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Contact: Kathleen Cosgrove
kathleen.cosgrove@mslpr.com
617-937-2534
Columbia Laboratories, Inc.
Source:Eurekalert

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