A multicenter study, led by researchers at Yale School of Medicine, showed for a low dose oral contraceptive with Drospirenone, a new progestin, and different dosing regimen is effective in treating symptoms of premenstrual dysphoric disorder ( PMDD ), the most severe form of premenstrual syndrome.

Premenstrual dysphoric disorder is characterized by cyclical mood, behavioral and physical symptoms that can be debilitating in some women.
The cause of PMDD is unknown, "although it is clear that changes in steroid hormone levels constitute a trigger for symptom production," said Kimberly Yonkers, of the Departments of Psychiatry and Epidemiology and Public Health and lead author of the study.

Symptoms are diminished by suppressing ovarian activity and can be provoked by hormones given to women who are no longer menstruating.

The aim of the study has been to compare the efficacy of a new low-dose oral contraceptive pill ( OCP ) formulation with placebo in reducing symptoms of premenstrual dysphoric disorder.

The 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 µg.
Hormones were administered for 24 days, followed by 4 days of inactive pills ( 24/4 ).

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 ( adjusted mean difference –7.5, 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; P = .003 ); physical symptom scores were reduced by –10.7 and –8.6 in active-treatment and placebo groups, respectively ( adjusted mean difference –2.1; P < .001 ); and behavioral symptom scores were reduced by –7.7 and –6.2 in active-treatment and placebo groups, respectively ( adjusted mean difference –1.5; P < .001 ).

Response, defined as a 50% decrease in daily symptom scores, occurred in 48% of the active-treatment group and 36% of the placebo group ( relative risk 1.7; P = .015 ) and corresponds to a number-needed-to-treat of 8 patients.

This study showed that a 24/4 regimen of Drospirenone 3 mg and Ethinyl-Estradiol 20 µg improves symptoms associated with premenstrual dysphoric disorder.

Source: Yale University, 2005


XagenaMedicine2005