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Columbia Laboratories and Watson Announce Publication of Positive Phase III PROCHIEVE® Vaginal Progesterone Gel Study Results
Date:4/6/2011

his important data broadly available for review by the scientific and medical community, we can work to educate health care providers on the benefits of cervical screening and ensure it becomes a standardized component of the prenatal care regimen, ensuring that pregnant women at potential risk are identified.  We are committed to working with Columbia to submit the NDA to FDA, and to work closely to achieve a thorough review of the data which we believe will ultimately support approval of this potential therapy."

Trial Design and ResultsThe PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) study was designed to evaluate the efficacy and safety of PROCHIEVE® (progesterone gel) to reduce the risk of preterm birth in women with a short cervical length as measured by transvaginal ultrasound between 19 and <24 weeks of gestation.  This double-blind, placebo-controlled study enrolled 465 healthy pregnant women between the ages of 15 and 45 at 44 sites in 10 countries.  Nearly half the subjects were based in the U.S.  Subjects were randomly assigned to receive either PROCHIEVE or placebo vaginal gel once daily from 20-24 weeks gestation until 37 weeks gestation, preterm rupture of membranes or delivery, whichever occurred first.  Women self-administered the progesterone gel study drug or gel placebo once daily in the morning.

The primary endpoint was a reduction in the rate of preterm birth before 33 weeks gestation.  This endpoint was chosen because the highest frequency of neonatal morbidity occurs with preterm neonates delivered prior to this gestational age. The incidence of preterm births was also evaluated before 28, 35 and 37 weeks gestation.  Analysis was by intention to treat, including all women randomized, and excluding patients lost to follow-up.

Results showed that women treated with PROCHIEVE had a significantly lower risk of preterm birth before 33 weeks gestation compared to those who
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SOURCE Watson Pharmaceuticals, Inc.; Columbia Laboratories, Inc.
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