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"FDA Clears Progesterone Gel"


May 23, 1997
NEW YORK (Reuters) - Women who are trying to get pregnant using in vitro fertilization may be able to avoid daily injections of progesterone, a hormone needed to prepare the uterus for embryo implantation. Instead, such women can use one or two daily applications of a progesterone-containing vaginal gel, called Crinone, to treat progesterone deficiency, a condition where the patient does not produce high enough levels of the hormone. The bioadhesive gel is the first approved by the Food and Drug Administration (FDA) to be used during infertility treatments, according to the Philadelphia-based Wyeth-Ayerst Laboratories, which will market the drug.

The product was developed by the pharmaceutical company, Columbia Laboratories. Currently, women undergoing infertility treatments use daily injections or vaginal suppositories to deliver the drug to the uterus to help embryo implantation and to maintain pregnancy for the first 12 weeks of gestation. “Crinone... is packaged in an easy-to-use, pre-filled vaginal applicator which avoids the pain of intramuscular (IM) injection, and the untidiness and inconsistency associated with vaginal suppositories,” says a statement from Wyeth-Ayerst. “This applicator and the technological breakthrough of a bioadhesive gel, allow Crinone to deliver progesterone via the vagina to the uterus.” 

This development in fertility research provides physicians an effective therapy alternative that is easier and more comfortable for patients to use,” according to Dr. Marc Deitch, senior vice president of medical affairs at Wyeth-Ayerst. In a study of 54 women undergoing an embryo transfer - a procedure in which a sperm and egg are combined in a laboratory dish and then transferred into a woman’s uterus - 31% became pregnant and delivered a baby when they used Crinone instead of other progesterone- delivery methods. The women, who lacked their own natural progesterone, and replaced the hormone with twice daily vaginal applications of the drug, reported side effects such as cramps, breast pain, and headache.



In a second study of 139 women undergoing in vitro fertilization (IVF) who had low natural levels of progesterone, a once daily application of the drug resulted in 23% becoming pregnant and delivering a child. Those women most often had side effects such as breast enlargement, constipation, sleepiness, nausea, and headache. The hormone should not be used in all women, according to the manufacturer. 

Women with progesterone sensitivity, undiagnosed vaginal bleeding, liver disease, known or suspected cancer in the breast or reproductive system, a history of blood clots or tissue in the uterus from a previous miscarriage, should not use Crinone. According to the manufacturer, the gel could be useful for other applications, such as for women on hormone replacement therapy who need to take progesterone to reduce the risk of uterine cancer associated with estrogen. And it could be used to treat young women with amenorrhea, or a cessation of menstruation due to vigorous activity or anorexia. However, the gel is not yet approved by the FDA for those applications.


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