This ongoing prospective randomized controlled study is evaluating pregnancy rates and successful long-term pregnancies in 400 women treated with CRINONE 8% progesterone vaginal gel versus compounded progesterone intramuscular injections. The study is being conducted by the Brigham and Women's Hospital in Boston.
The interim analysis compared pregnancy rates and patient preferences among 215 patients who had completed 20 weeks of pregnancy. Patients were randomized to receive CRINONE 8% (n = 105) or IMP (n = 110). Pregnancy rates, implantation rates, and early spontaneous abortion rates were similar in both arms of the study, whereas fewer side effects and greater overall satisfaction were reported by women receiving CRINONE 8%.
"The fact that CRINONE 8% delivers the progesterone needed to achieve and maintain pregnancy has been widely established in numerous clinical studies. This study by Brigham and Women's Hospital is also evaluating patient satisfaction, which is increasingly important given the trend toward patients taking a more active role in deciding their treatment regimens," stated Robert S. Mills, president and chief executive officer of Columbia Laboratories.
"The interim analysis shows women receiving CRINONE 8% reported fewer side effects and greater overall satisfaction versus women receiving IMP. This comes as no surprise, considering their differences. The IMP is administered as a deep intra-muscular injection, with injection site pain and potential irritation and infection. CRINONE 8% bioadhesive vaginal gel is self-administered at home once a day using a convenient, patient-friendly, pre-filled applicator."
The full in-press article is available for purchase at http://www.fertstert.org/article/PIIS0015028207005407/abstract and will soon appear in the print version.
About Fertility and Sterility
Fertility and Sterility, known as "the red journal," publishes juried original articles of scientific excellence in clinical and laboratory research relevant to reproductive endocrinology, physiology, immunology, genetics and menopause. Citation analysis indicates that it is among the most frequently referenced scientific journals and has the highest immediacy and impact factors in the field of reproductive medicine. The journal is an indispensable resource to reproductive endocrinologists, obstetricians, gynecologists, urologists, and basic scientists who treat and investigate the problems of fertility, sterility and the physiology of reproduction.
About Columbia Laboratories
Columbia Laboratories, Inc. is a is a specialty pharmaceutical company focused on developing and marketing products for the women's healthcare and endocrinology markets using its novel bioadhesive drug delivery technology. Columbia markets CRINONE(R) 8% (progesterone gel) and PROCHIEVE(R) 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency and PROCHIEVE 4% (progesterone gel) for the treatment of secondary amenorrhea. The Company also markets STRIANT(R) (testosterone buccal system) for the treatment of hypogonadism in men. The Company's research and development programs include a vaginally-administered lidocaine product to prevent and treat dysmenorrhea. For more information, please visit www.columbialabs.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: Th is press release contains forward-looking statements about Columbia Laboratories, Inc.'s expectations regarding the Company's strategic direction, prospects and future results, and clinical research programs, 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 following: the successful marketing of CRINONE(R) 8% (progesterone gel), PROCHIEVE(R) 8% (progesterone gel), PROCHIEVE 4% (progesterone gel), and STRIANT(R) (testosterone buccal system) in the U.S.; the timely and successful development of new products, including determining the clinical and regulatory path for possible development of PROCHIEVE 8% for the prevention of preterm birth; the timely and successful completion of clinical studies, including the clinical studies for our vaginally-administered lidocaine product candidate; success in obtaining acceptance and approval of new products and new indications for current products by the FDA and international regulatory agencies, 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.
CRINONE(R), PROCHIEVE(R) and STRIANT(R) are registered trademarks of Columbia Laboratories, Inc.
Columbia Laboratories, Inc.
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