Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder

Objective: To compare the efficacy of a new low-dose oral contraceptive pill (OCP) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder. Methods: This multicenter, double-blind, randomized clinical trial consisted of 2 run-in and 3 treatment cycles with daily symptom charting; 450 women with symptoms of premenstrual dysphoric disorder were randomized to either placebo or an OCP formulation containing drospirenone 3 mg and ethinyl estradiol 20 mu g. Hormones were administered for 24 days, followed by 4 days of inactive pills (24/4). Results: Scores on the total Daily Record of Severity of Problems decreased by -37.49 in the drospirenone/ethinyl estradiol group and by -29.99 in the placebo group (ad-justed mean difference -7.5, 95% confidence interval vertical bar Cl vertical bar -11.2 to -3.8; P < .001 by rank analysis of covariance). Mood symptom scores were reduced by -19.2 and -15.3 in active-treatment and placebo groups, respectively (adjusted mean difference -3.9, 95% Cl -5.84 to -2.01; P = .003); physical symptom scores were reduced by -10.7 and -8.6 in active-treatment and placebo groups, respectively (ad-justed mean difference -2,1, 95% Cl 3.3 to -0-95; P < .001); and behavioral symptom scores were reduced by -7.7 and -6.2 in active-treatment and pla(ebo groups, respectively (adjusted mean difference -1.5, 95%, Cl -2.251 to -0.727; P < .001. Response, definod as a 501% decrease in daily symptom scores, OCCUrred in 48% of the activetreatment group and 36% of the placebo group (relative risk 1.7, 95%, Cl 1.1 to 2.6; P = .015) and corresponds to a number-needed-to-treat of 8 patients. Conclusion: A 24/4 regimen of drospirenone 3 mg and ethinyl estradiol 20 mu g improves symptoms associated with premenstrual dysphoric disorder.