Treatment of Premenstrual Syndrome Using Danazol: Preliminary Report of a Placebo-Controlled, Double-Blind, Dose Ranging Study

Introduction The premenstrual syndrome (PMS) is a common condition in which a cluster of psychological and/or physical symptoms recur in the post-ovulatory phase of the cycle, subsiding with the onset of menstruation and not usually re-appearing before ovulation. The precise aetiology of PMS is obscure. Though hormone-related, no consistent hormonal defect has been shown. Whilst a variety of treatments are employed, including progesterone, dydrogesterone, pyridoxine and diuretics, proof of their value from doubleblind studies is limited. Danol (danazol) is a synthetic derivative of ethisterone which inhibits the production and activity of sex steroids by effects on the hypothalamo-pituitary gonadal system as well as on the target organ itself (Barbieri & Ryan 1981). Danol has been selected for this double-blind study in PMS following report of its potential usefulness (Day 1979).