CLINICAL TRIAL
COMPARATIVE STUDY
EVALUATION STUDIES
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
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Evaluation of a unique oral contraceptive (Yasmin) in the management of premenstrual dysphoric disorder.

Over three-quarters of women experience some physical and emotional changes associated with the menstrual cycle. Irritability, tension, fatigue, depression, breast tenderness and bloating are among the most common premenstrual symptoms. Approximately 5-10% of women of childbearing age experience premenstrual symptoms to a degree that disrupts their functioning in the home or workplace and that meet criteria for premenstrual dysphoric disorder (PMDD). Serotonergic antidepressants are clearly effective for PMDD, with about 60% of subjects responding to this treatment in controlled studies. Oral contraceptives are commonly used to treat premenstrual symptoms but are an understudied intervention with no information on their efficacy for PMDD). The recent introduction of an oral contraceptive (Yasmin, Schering AG, Berlin, Germany), containing low-dose ethinylestradiol (EE) combined with a new progestogen, drospirenone (DRSP), may offer clinical efficacy for PMDD as a result of the unique pharmacological profile of this progestogen, which is a spirolactone derivative with antimineralocorticoid and antiandrogenic activity. A randomized, placebo-controlled study of DRSP/EE in women with PMDD found a consistently greater reduction of symptoms-from baseline for all 22 premenstrual symptoms assessed (using the Calendar of Premenstrual Experiences, COPE) and for the four statistically derived symptom factors in the group taking DRSP/EE compared to the placebo group. For appetite, acne and food craving (factor 3), the difference between the DRSP/EE group and the placebo group was statistically significant (p = 0.027). These preliminary results suggest the beneficial effect of DRSP/EE on PMDD and offer an alternative class of medication that also provides the range of benefits of oral contraception for women with PMDD.

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