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A multi-center, open-label, randomized, controlled, parallel-group study to assess efficacy and safety of an extended flexible regimen of the combined oral contraceptive SH T00186D (0.02 mg ethinylest...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-004899-13

A multi-center, open-label, randomized, controlled, parallel-group study to assess efficacy and safety of an extended flexible regimen of the combined oral contraceptive SH T00186D (0.02 mg ethinylestradiol as beta-cyclodextrin clathrate and 3 mg drospirenone) compared to the conventional regimen of SH T00186D in the treatment of primary dysmenorrhea

Femme Homme

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Extrait

To evaluate efficacy and safety of the combined oral contraceptive [COC] SH T00186D (0.02 mg ethinylestradiol [EE]; 3 mg drospirenone [DRSP]) applied in a conventional and an extended flexible regimen in the treatment of moderate to severe primary dysmenorrhea Primary efficacy variables: • Number of days with dysmenorrheic pain over 140 days of treatment

Critère d'inclusion

  • women suffering from primary dysmenorrhea

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