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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF A COMBINATION OF LEVONORGESTREL AND ETHINYL ESTRADIOL IN A CONTINUOUS DAILY REGIMEN IN SUBJECTS WITH PREMENSTRUAL DYSPHORIC DISORDE...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-005173-27

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF A COMBINATION OF LEVONORGESTREL AND ETHINYL ESTRADIOL IN A CONTINUOUS DAILY REGIMEN IN SUBJECTS WITH PREMENSTRUAL DYSPHORIC DISORDER

Femme Homme

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Extrait

To evaluate the effect of treatment with LNG/EE administered in a continuous daily regimen versus placebo on the mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score from baseline to the cycle 1 efficacy period and from baseline to the last on-therapy efficacy period.

Critère d'inclusion

  • Premenstrual dysphoric disorder (PMDD) affects 3% to 5% of menstruating women. PMDD is defined by markedly depressed mood, anxiety, and/or affective lability during the last week of the late luteal phase with absence of these symptoms in the postmenses week. These symptoms markedly interfere with work or school or with usual social activities and relationships with others. Suppression of ovarian cyclicity is known to alleviate symptoms of PMDD

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