Infertility
Prochieve Gel Doubles the Rate of Pregnancy in Infertile Women on Clomiphene
By Columbia Laboratories, Inc.
Jun 21, 2005 - 9:33:00 PM

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.

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