Evaluation of a unique oral contraceptive in the treatment of premenstrualdysphoric disorder

Premenstrual dysphoric disorder (PMDD) is a severe form of premenstrual syn drome (PMS). This is the first trial of a unique oral contraceptive contain ing a combination of drospirenone (DRSP, 3 mg) and ethinyl estradiol (EE, 3 0 mug) for the treatment of PMDD. DRSP is a spironolactone-like progestin w ith antiandrogenic and antimineralocorticoid activity. Spironolactone has b een shown to be beneficial in PMS, whereas oral contraceptives have shown c onflicting results. In this double-blind, placebo-controlled trial, 82 wome n with PMDD (Diagnostic and Statistical Manual of Mental Disorders, 4th ed. [DSM IV]) were randomized to receive DRSP/EE or placebo for three treatmen t cycles. The primary end point was change from baseline in luteal phase sy mptom scores as assessed on the Calendar of Premenstrual Experiences (COPE) scale. Patients treated with DRSP/EE showed a numerically greater change f rom baseline compared with those treated with placebo on each of the 22 COP E items and each of the 4 symptom factors. Between-group differences in sym ptom improvement reached statistical significance in factor 3 only (appetit e, acne, and food cravings, p = 0.027). The secondary end points, Beck Depr ession Inventory (BDI) and Profile of Mood States (PMS), were consistent wi th the primary end point in that patients treated with the oral contracepti ve showed a numerically greater improvement from baseline compared with tho se treated with placebo. The results of this study show a consistent trend in the reduction of symptoms that suggested a beneficial effect of DRSP/EE for the treatment of PMDD, despite limitations of the study design.