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Data From Meta-Analysis Show Clinical Pregnancy Rate With Vaginal Progesterone is Comparable With Intramuscular Progesterone When Administered at Optimal Dosing in Infertility Patients
2009 MAY 25 - (NewsRx.com) -- Columbia Laboratories, Inc. (Nasdaq:CBRX) announced that the full report of a meta-analysis evaluating vaginally-administered progesterone versus intramuscular (IM) progesterone injections in infertility patients is available online. CRINONE® 8% was the vaginal treatment used in five out of the seven studies analyzed. Key findings of the meta-analysis show that the clinical pregnancy rate with vaginal progesterone is comparable with IM progesterone when administered at optimal dosing, and that vaginal progesterone is associated with a significantly lower rate of miscarriage than IM progesterone. The meta-analysis was initially published as an abstract and presented at the American Society of Reproductive Medicine (ASRM) annual meeting in 2007. The study was accepted for publication in Fertility and Sterility, the official journal of ASRM. The meta-analysis was conducted by Paul W. Zarutskie, M.D., of the Zarutskie Fertility and Endocrine Institute, Seattle, Washington. The study includes data from previously conducted randomized clinical trials meeting acceptance criteria combined with recent research results. The main outcome measures of the study were clinical pregnancy, ongoing pregnancy and miscarriage rates in women undergoing progesterone treatment as part of an assisted reproductive technology regimen. “This analysis adds to a growing body of clinical research that provides the data necessary to change the paradigm of luteal phase support for assisted reproductive technology from IM to vaginally administered progesterone,” said Dr. Zarutskie. Robert S. Mills, president and chief executive officer of Columbia Laboratories, stated, “We are very pleased with these results, which support and magnify the outcomes of previous clinical trials of CRINONE® 8% demonstrating its benefits versus IM progesterone in helping women undergoing infertility treatments to achieve and sustain a viable pregnancy.” The meta-analysis abstract can be accessed via the following link: http://www.ncbi.nlm.nih.gov/pubmed/19362303'ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum. About CRINONE® 8% CRINONE® 8% was the first FDA-approved natural progesterone for progesterone supplementation or replacement as part of Assisted Reproductive Technology (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. Keywords: Clinical Research, Clinical Trial Research, Drugs, Endocrine, Hormones, Obstetrics, Pharmaceuticals, Pregnancy, Progesterone, Reproductive Health, Spontaneous Abortion, Therapy, Treatment, Women's Health, Columbia Laboratories Inc. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.
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