Interim Results of Treatment Protocol Positive on Crinone(R)
Clinical Efficacy in Assisted Reproduction Without Painful Injections
Only Progesterone Product Approved by the FDA for Application
in Infertile Women
NORWELL, Mass., Sept. 27 /PRNewswire/ -- An interim analysis of the largest treatment protocol to date on progesterone supplementation in women undergoing assisted reproductive technologies (ART) demonstrates that Crinone(R) (progesterone gel) treatment is associated with excellent clinical pregnancy rates and is convenient for patients. Patients involved in the treatment protocol achieved clinical pregnancy rates of 35.2 percent. Moreover, Crinone's unique administration allows patients the convenience and benefits of progesterone therapy without undergoing painful intramuscular injections.
The interim findings will be announced this week during the Conjoint Annual Meeting of the American Society for Reproductive Medicine and the Canadian Fertility and Andrology Society in Toronto.
"This interim data suggests that women can achieve results with Crinone that are at least as good as or may exceed those obtained with other progesterone formulations," said David Keefe, M.D., Women and Infants Hospital, Providence, Rhode Island. "Although a final analysis is necessary to draw firm conclusions, our sample size gives us confidence in the trends seen, thereby supporting vaginal administration of progesterone using a sustained-controlled release delivery system."
Crinone (progesterone gel) is the only progesterone product approved by the FDA for use in ART procedures. Crinone is a progesterone gel that is administered vaginally once or twice daily using a pre-filled, disposable applicator. Crinone utilizes polycarbophil, a patented bioadhesive gel that promotes adherence to the vaginal lining for up to 72 hours while reducing risk of leakage experienced with some other products. It is based in an oil-in-water emulsion that provides a controlled and sustained release of progesterone, which then diffuses from the vagina to the uterus, for complete endometrial transformation.
Progesterone is a hormone that prepares the lining of the uterus (endometrium) for implantation of a fertilized egg and supports the early stages of pregnancy until the placenta is developed. Progesterone products are administered in infertility treatments to supplement or replace the body's natural supply of the hormone.
Interim Analysis Shows Benefit
Crinone is currently undergoing a treatment protocol study in the US involving approximately 2,000 patients at 23 infertility treatment centers. This interim analysis includes the experiences of 1,251 women in 16 centers undergoing in vitro fertilization studied in 1997-98. Of these, 35.2 percent of Crinone patients achieved a clinical pregnancy. Further, for patients whose data has been fully analyzed, of 590 patients receiving Crinone in combination with follicle stimulating hormone (FSH), 34.9 percent achieved a clinical pregnancy as compared to 25.7 percent of 210 patients receiving Crinone in combination with human menopausal gonadotropin (hMG).
"The results of this study are good news for many patients who currently rely on painful intramuscular injections or other inconvenient and messy applications of progesterone therapy," Dr. Keefe added.
As part of the treatment protocol, patients were asked to describe their experiences with progesterone therapies. Participants reported that they preferred Crinone to other forms of progesterone treatments, specifically intramuscular injections and suppositories. Of patients who had previously undergone a different form of progesterone treatment, 91 percent of patients (n = 420) preferred Crinone to intramuscular injections and 90 percent of patients (n = 463) preferred Crinone to suppositories. In describing their overall experience using Crinone, 94.4 percent of patients (n = 1,018) found Crinone easy to administer, 94.9 percent (n = 1,016) reported no pain with Crinone and 74.6 percent (n = 1,018) considered Crinone not to be messy.
In addition to its use in ART, Crinone is also indicated for secondary amenorrhea. Previous studies have established that Crinone is well tolerated. The most common side effects reported for patients receiving the drug for progesterone supplementation include breast enlargement, constipation, somnolence and nausea. In patients receiving progesterone replacement therapy in ART with Crinone, the most common side effects include cramps, breast pain and headache.
Crinone should not be used by individuals with any of the following conditions: 1) known sensitivity to Crinone (progesterone or any of the other ingredients); 2) undiagnosed vaginal bleeding; 3) liver dysfunction or disease; 4) known or suspected malignancy of the breast or genital organs; 5) missed abortion; 6) active thrombophlebitis or thromboembolic disorders, or a history of hormone associated thrombophlebitis or thromboembolic disorders.
Ares-Serono recently acquired exclusive marketing rights for Crinone from Wyeth-Ayerst Pharmaceuticals, the pharmaceutical division of American Home Products Corporation. Crinone was developed by Columbia Laboratories (Amex: COB) and is manufactured by Columbia Laboratories.
Serono Laboratories, Inc. is the U.S. affiliate of Ares-Serono S.A., a leading biotechnology company headquartered in Geneva, Switzerland. The world leader in reproductive health, Ares-Serono is also active in growth/metabolism and multiple sclerosis/immunology. With 1998 sales of US $918 million, Ares-Serono operates in 45 countries and its products are sold in more than 100 countries. Shares of Ares-Serono S.A., the holding company of the group, are traded on the Swiss stock exchange (Zurich: AREB).
To obtain a copy of the package insert for Crinone, please contact PR Newswire's Fax on Demand Service at 1-800-753-0352, ext. 700, or Serono's Product Information and Surveillance Group, weekdays 9 a.m. to 5 p.m., Eastern Time, at 1-800-283-8088 ext. 5562.
CONTACT: Carolyn Castel of Serono Laboratories, 781-681-2340; or
Lisa Garb of Landmark Communications, 201-567-4242,
for Serono Laboratories.
SOURCE Serono Laboratories, Inc.
CO: Serono Laboratories, Inc.; Ares-Serono S.A.
ST: Massachusetts
IN: MTC
SU: PDT
09/27/1999 08:33 EDT prnewswire.com |
