Women who were counting on Procter and Gamble’s new drug, Intrinsa, to spice up their sex lives will have to wait a little longer. Yesterday, the Food and Drug Administration turned down a request by the pharmaceutical giant to approve the drug for general distribution.

Their reasoning was that there is not enough data to warrant approval. Additionally, because the drug must be taken in combination with estrogen, women may be at an increased risk of developing breast cancer or suffering a stroke or heart attack. In fact, three of the four women who developed breast cancer during the trials were taking Intrinsa.

Women who participated in the clinical studies testified as to the drug’s effectiveness. Roslyn Washington of Maryland told the panel that the drug definitely restored her libido. Ms. Washington, who is 51, had a hysterectomy in 1994. Procter and Gamble spokesperson, Elaine Plummer, testified that many of the women had similar reactions.

Intrinsa administers a low dosage of testosterone via a patch that is placed on the abdomen twice a week. Testosterone is a major factor in elevating a woman's sex drive. Approximately half of a woman's testosterone is produced in the ovaries. Women in menopause and those who have had hysterectomies no longer produce testosterone and many complain of a reduction in their libido as a result.

The panel also cited side-effects of the drug as reason to turn down P&G’s request. Some of the participants reported having acne problems and growing facial hair. The clinical trials were only conducted with women who had hysterectomies. One of the panel's expressed concerns was that if the drug were to be approved for this group, physicians would be free to offer it to menopausal women and that there is no data on how this drug affects this large group of women.

The seventeen member panel included a mix of men and women at several gynecologists. Their decision was unanimous.