Prochieve Gel Doubles the Rate of Pregnancy in Infertile Women on Clomiphene
Jun 21, 2005, 21:33, Reviewed by: Dr.
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"This study suggests a new treatment modality that may help improve the rate of pregnancy by using a timed sequence of hormone supplementation following clopmiphene citrate therapy."
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By Columbia Laboratories, Inc. ,
Columbia Laboratories, Inc. (NASDAQ: CBRX) today announced that data from a pilot study investigating the effects of hormone supplementation following clomiphene citrate therapy has been published in the July issue of Current Medical Research and Opinion and is currently available online.
The study suggests that administering a sequential estrogen and progesterone supplementation regimen, including Prochieve(R) 8%, with clomiphene citrate (CC) cycles in oligo-ovulatory and anovulatory women may more than double the rate of pregnancy, as compared to clomiphene citrate therapy alone, but, because this was a pilot study, the difference did not reach statistical significance.
The study, entitled "Conception rates in clomiphene citrate cycles with and without hormone supplementation: a pilot study," was a randomized, open-label study performed in the United States. Of the 71 evaluable patients, 34 women were treated with CC followed by oral estradiol and Prochieve 8% (CEP Regimen), while 37 received CC alone. Cycle one data demonstrated a clinically meaningful trend for pregnancy rates in the CEP Regimen arm, which were more than double the control arm.
"This study suggests a new treatment modality that may help improve the rate of pregnancy by using a timed sequence of hormone supplementation following clopmiphene citrate therapy," said the study's lead investigator Karen E. Elkind-Hirsch, MSc, PhD, scientific director of research, Woman's Health Research Institute, Woman's Hospital, Baton Rouge, LA. "Although the data did not achieve statistical significance, these clinically significant pilot data show that an improved regimen for CC therapy using the CEP Regimen merits further investigation."
This study enrolled 88 women, 21 to 35 years of age, whose confirmed anovulatory and oligo-ovulatory condition would typically lead to fertility treatments. All patients were treated with 100 mg clomiphene citrate orally for Days 3 to 7 of the cycle. Starting on Day 8, patients in the CEP Regimen arm also received 3 mg oral estradiol twice daily until detection of a surge in luteinizing hormone (LH) levels. Intercourse was encouraged starting on Day 10. Three days after the LH surge, patients in the CEP Regimen arm began treatment with Prochieve(R) 8% (progesterone gel); daily use of Prochieve 8% continued for two weeks, followed by a pregnancy test. If pregnant, all patients in the CEP Regimen arm received Prochieve 8% for an additional 10 weeks.
"We are very excited about the positive outcomes of this pilot study," stated Fred Wilkinson, Columbia's President and Chief Executive Officer. "The clinical benefits demonstrated by an improved clomiphene citrate regimen highlight the need for new methods to help infertile women achieve and sustain pregnancy. We are currently designing a larger, multi-center study to further evaluate the CEP Regimen based on these findings."
About Prochieve 8%
Prochieve 8% (progesterone gel) is a bioadhesive product that is approved by the U.S. Food and Drug Administration (FDA) for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency.
Prochieve 8% utilizes Columbia Laboratories' proprietary Bioadhesive Delivery System to deliver progesterone vaginally in a convenient and easy-to-use pre-filled, tampon-like applicator. Using a non-immunogenic (hypo-allergenic) bioadhesive polymer designed to adhere to the vaginal tissue, Prochieve 8% promotes controlled and sustained absorption of progesterone and minimizes leakage, a side effect commonly seen with vaginal suppositories. As a result, the product does not restrict normal activities. Prochieve 8% contains 90 mg of natural progesterone. It is FDA approved and safe for use during pregnancy.
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. 
- The study has been published in the July issue of Current Medical Research and Opinion and is currently available online
www.columbialabs.com
About Columbia Laboratories
Columbia Laboratories, Inc. is a U.S.-based international pharmaceutical company dedicated to the development and commercialization of women's health care and endocrinology products. Columbia markets Prochieve(R) 8% (progesterone gel) for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency and Prochieve(R) 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. Columbia's products and product candidates utilize the company's bioadhesive drug delivery technology, which is able to deliver a broad range of compounds, including peptides, across many of the body's mucosal surfaces to address numerous therapeutic areas. The Company is investigating the potential utility of Prochieve 8% in the prevention of preterm birth and developing a vaginally-administered lidocaine product to treat dysmenorrhea and pelvic pain. For more information, please visit www.columbialabs.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: Except for historical information contained herein, certain statements of Columbia Laboratories, Inc.'s expectations made in this press release, including those regarding the Company's clinical research programs, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Those statements include statements regarding the intent, belief or current expectations of Columbia Laboratories and its management team. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements. Given these uncertainties, investors should not place undue reliance on these forward-looking statements. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of Striant(R), Prochieve(R) 8% and Prochieve(R) 4% in the United States; the timely and successful development of products; the timely and successful completion of clinical studies, including the study of Prochieve 8% in the prevention of preterm birth and the study of lidocaine vaginal gel in the treatment of dysmenorrhea and pelvic pain; success in obtaining acceptance and approval of new products and 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 health care 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.
Striant(R) and Prochieve(R) are registered trademarks of Columbia Laboratories, Inc.
Contact Columbia Laboratories, Inc. David Weinberg, 973-994-3999 x7933 or Rx Communications Group, LLC Melody A. Carey, 917-322-2571
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