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Executive Summary

FDA REQUESTING PHASE IV STUDIES OF PHASIC ORAL CONTRACEPTIVES to examine whether the products are associated with functional ovarian cysts. In a letter to Syntex, Ortho and Wyeth -- the three firms with NDAs for triphasic oral contraceptives -- FDA asked the companies to "undertake a Phase IV clinical study to determine if an association may exist between the use of phasic oral contraceptives and functional ovarian cysts." The agency added that it would be "pleased to review and comment on your protocol before you undertake the study." The letter to the contraceptive manufacturers, written by FDA Metabolism and Endocrine Drug Products Division Director Solomon Sobel, MD, explains that "within the last several months the agency has received a number of adverse reaction reports of functional ovarian cysts occurring in women taking oral contraceptives." According to FDA, approximately 30 reports of ovarian cysts in phasic oral contraceptive users have shown up through the reporting system since 1984. FDA was also alerted to the possible association by an anecdotal study of seven women who developed ovarian cysts while using phasic oral contraceptives. FDA noted that the study, which appeared in the June 1987 issue of the American Journal of Obstetrics and Gynecology, has brought these observations to the attention of other physicians." Sobel warned that "it would be necessary to change the labeling of phasic oral contraceptives . . . if a causal relationship were established." An FDAer familiar with the study and the agency's concerns said FDA is requesting the additional studies because the association between the contraceptives and ovarian cysts is not clear. The FDAer noted that the study combined with other evidence indicate that while the phasic contraceptives may not actually cause cysts, they do not suppress cyst formation as strongly as higher dose monophasic contraceptives. None of the companies contacted by FDA have yet begun Phase IV studies looking at ovarian cysts. Wyeth, which manufactures Triphasil phasic oral contraceptives, said it is is holding discussions internally and with FDA to discuss the possibility of initiating a study. Ortho said it is still reviewing FDA's letter and has not yet made a decision regarding Phase IV studies of its Ortho Novum 7/7/7 contraceptive. Syntex, which markets Tri-Norinyl, said it is in discussions with the agency on how to do "an appropriate followup" to determine if there is "any substance" to the study published last summer.

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