Largest Study Demonstrates Comparable Pregnancy Outcomes Using Vaginal Gel versus Injectable Progesterone, with Frozen Embryos from Donor Eggs
LIVINGSTON, N.J. & SAN FRANCISCO--(BUSINESS WIRE)--Nov 10, 2008 - The largest retrospective analysis to date, conducted at Boston IVF, a Harvard Medical School affiliate, is the first to demonstrate that there were no significant differences in pregnancy outcomes for recipients of previously frozen embryos from donor oocytes (eggs), in patients using vaginally-administered progesterone gel (CRINONE(R) 8%) versus progesterone injected intramuscularly (IM). This analysis showed that the two groups were comparable in all clinical parameters, and had no significant differences in pregnancy outcomes (clinical pregnancy, implantation, delivery and total pregnancy loss rates). These data are available online at www.fertstert.org.
This retrospective analysis compared pregnancy outcomes in 279 recipients of previously frozen embryos from donated oocytes during a four year time period. Frozen embryo transfer (FET) recipients received either CRINONE 8% progesterone gel (90 mg BID) or IM progesterone (50 mg).
"Our objective was to compare pregnancy outcomes between two progesterone replacement regimens used for recipients of previously frozen embryos from donated oocytes," said Brian M. Berger, MD, Boston IVF, and lead author of the study. "This study design also allowed for a more accurate assessment of the contributions of progesterone administered during infertility treatment, because recipients of previously frozen embryos do not have a functioning corpus luteum to produce their own progesterone."
Patients receiving CRINONE 8% achieved a clinical pregnancy rate of 34.1% and a delivery rate of 25.9%; patients receiving IM progesterone had a clinical pregnancy rate of 35.2% and a delivery rate of 25.3%. Implantation rates were 24.1% and 22.7% for CRINONE 8% and IM progesterone, respectively. "The demonstration of comparable pregnancy outcomes using CRINONE versus IM progesterone offers infertile women an option other than painful injections when undergoing frozen embryo transfer procedures," said Dr. Berger.
About Progesterone and Luteal Phase Support
Progesterone is a hormone naturally found in a woman's body, which creates a healthy environment in the uterus, where a fertilized egg can implant and grow into a healthy pregnancy. Most women undergoing infertility treatment need additional progesterone, to help prepare the uterus for implantation and development of a fertilized egg.
Before ovulation, progesterone levels in a woman's body remain relatively low, but rise after ovulation, during the luteal phase. The luteal phase is the latter part of a woman's menstrual cycle. It begins with the production of progesterone and ends with either pregnancy or menstruation, when the uterus sheds its lining. During pregnancy, progesterone helps to maintain the lining of the uterus, providing necessary nutrients to support and nurture a fertilized egg.
This study was supported by a grant from Columbia Laboratories, Inc.
Boston IVF is one of America's most successful fertility centers, providing patients with unparalleled medical care and the best experience with the expertise of premier doctors and professional staff, who are affiliated with Harvard Medical School. It is world renowned for its highly successful and innovative infertility treatments, highest quality service, state-of-the-art methods, ongoing scientific research, and on-site complementary healthcare at its Domar Center.
About CRINONE(R) 8%
CRINONE (R) 8% was the first FDA-approved natural progesterone for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatments for infertile women with progesterone deficiency, and is the only approved once daily treatment. CRINONE 8% is the only treatment approved for progesterone replacement when used twice a day. CRINONE 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. For more information, please visit www.crinoneusa.com.
The most common side effects of CRINONE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 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.
CRINONE(R) is a registered trademark of Columbia Laboratories, Inc.
About Columbia Laboratories
Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women's healthcare and endocrinology products that use its novel bioadhesive drug delivery technology. Columbia markets CRINONE(R) 8% (progesterone gel) in the United States for progesterone supplementation as part of ART treatments for infertile women with progesterone deficiency. For more information, please visit www.columbialabs.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This press release may contain forward-looking statements about Columbia Laboratories, Inc.'s expectations regarding the Company's strategic direction, prospects and future results, which statements may be indicated by the words "will," "plan," "expect" and similar expressions. Such forward-looking statements are subject to certain risks and uncertainties; actual results may differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to the successful marketing of CRINONE(R) 8% (progesterone gel) in the U.S.; the timely and successful development of new products; the impact of competitive products and pricing; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the Securities and Exchange Commission. Columbia Laboratories undertakes no obligation to publicly update any forward-looking statements.
EDITOR'S NOTE: For a full copy of the study, please contact Gina Cella, Cella Communications (tel: 781-334-4692 or at ginacella@comcast.net).
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