The overall Phase III study, Progesterone Vaginal Gel for the Reduction of Recurrent Preterm Birth: Primary Results from a Randomized, Double-blind, Placebo-controlled Trial, did not show a beneficial effect of progesterone treatment on reducing the frequency of preterm birth in a larger population of high-risk women identified with only a history of spontaneous preterm birth.
Progesterone is a natural hormone found in all women, though levels of progesterone increase during pregnancy. Progesterone is also a well-established hormonal supplement required for successful infertility treatments.
About PROCHIEVE 8%
PROCHIEVE 8% is natural progesterone FDA-approved for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency. Several trials showing these benefits have been published. PROCHIEVE 8% is safe for use during pregnancy, and has been safely used for a decade by tens of thousands of women globally to help sustain pregnancy in the first trimester. Its unique bioadhesive delivery system provides controlled and sustained release of progesterone directly where it is needed.
The most common side effects of PROCHIEVE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. PROCHIEVE 8% is contraindicated in patients with active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs. For more information, please visit www.prochieve8.com.
|Contact: Kathleen Cosgrove|
Columbia Laboratories, Inc.