Treatment of premenstrual syndromes with progesterone antagonists (e.g., RU-486): political and methodological issues

The effect of political and social considerations on development and availability of medication is exemplified by the debate of the progesterone antagonist RU-486 and its indications. Premenstrual syndromes (PMS) are quite prevalent. In some women they are severe enough to warrant treatment, but at present there is no single treatment modality that has been shown to be effective with most women with PMS. Increased levels of progesterone and/or its fluctuations during the luteal phase have been suggested as possible factors in the pathophysiology of PMS. Therefore, progesterone antagonists represent a very promising avenue for treatment of a subgroup of PMS, and some other hormonally-related dysphoric disorders as well. Regretfully, because of the abortant properties of these compounds, they are the subject of a fierce debate and political considerations in the United States, and their availability for treatment trials of other indications in women is limited. It is hoped that progesterone antagonists will eventually be introduced for studies of their treatment and efficacy when indicated.