Vaginal Progesterone is Equally Effective and Results in Lower Miscarriage Rates Than Injectable Progesterone in Infertility Treatment
The original analysis published in 2006 of 10 studies (a meta-analysis) included research with different vaginal progesterone preparations - including oil capsules, vaginal cream and CRINONE(R) 8% (a bioadhesive progesterone gel) - using a wide range of doses. The re-analysis conducted by Dr. Zarutskie included eight studies; six studies of CRINONE 8% once daily and two studies of 200 mg of progesterone in oil capsules, administered three times daily, versus IM progesterone.
"Our objective was to analyze the existing data and new data published in 2006, but without including studies that used suboptimal doses of progesterone, to get an unbiased, true comparison. Our re-analysis shows no difference in the clinical pregnancy rate between IM and vaginal progesterone administration for luteal phase support in in vitro fertilization, when using optimal dosing of vaginally administered progesterone," said Dr. Zarutskie. "Importantly, these data also show a significantly reduced rate of miscarriage with CRINONE 8% and progesterone in oil capsules over IM progesterone dosing."
"These data are important in helping us to more clearly define an appropriate and effective standard of practice when prescribing progesterone for early pregnancy support following infertility treatment," Zarutskie added. "Studies have demonstrated that infertility patients prefer once daily CRINONE 8% over IM progesterone, vaginal suppositories and capsules. Now clinicians can feel confident in prescribing a proven bioadhesive gel formulation that delivers equal efficacy and patient comfort and convenience for women undergoing ART."
Dr. Paul W. Zarutskie is an internationally recognized leader in the fields of infertility and reproductive endocrinology. He is board-certified in both reproductive endocrinology and obstetrics and gynecology.
About Progesterone and Luteal Phase Support
Progesterone is the pregnancy hormone that creates a healthy environment in a woman's 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 latter part of a woman's menstrual cycle which is called the luteal phase. The luteal phase 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.
About CRINONE(R) 8%
CRINONE(R) 8% was the first FDA-approved natural progesterone for progesterone supplementation or replacement as part of ART treatment for infertile women with progesterone deficiency, and is the only once a day treatment. 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 Assisted Reproductive Technology treatment 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 contains forward-looking statements about Columbia Laboratories, Inc.'s expectations regarding the Company's strategic direction, prospects and future results, which statements are 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 copy of the re-analysis, please contact Gina Cella, Cella Communications (tel: 781-334-4692 or at ginacella@comcast.net).
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Posted: October 2007
