The Menstrual Cycle: A Double-Blind Study of Symptoms, Mood and Behavior, and Biochemical Variables Using Enovid and Placebo

Abstract

Enovid and a placebo were administered, in a double-blind crossover design, to 8 women volunteers for four cycles each. Throughout six phases of the cycle, data were collected on 120 symptom, mood and behavior, and biochemical variables. Mood and behavior were assessed using self-rating, interview rating and free association test (FAT). Thirteen of the variables showed cyclic variation independent of drug treatment. The fluctuations observed during placebo cycles were consistent with Benedek and Rubinstein's classic somatopsychic model of the sexual cycle in women. Enovid treatment resulted in shorter and more regular cycles, some relief of menstrual symptoms, certain somatic side effects, tranquilization, increased total plasma cortisol, slightly decreased basal plasma free fatty acid, and no change in urinary catecholamine levels. Enovid also eliminated the cyclic variation in FAT Anxiety observed during placebo cycles. The three methods of behavioral assessment produced scores which were, at best, only weakly correlated.