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Monocenter, open-label, randomized study to determine the ovulation inhibitory effect of the combined oral contraceptives SH T04769G (0.015 mg Ethinylestradiol and 1.5 mg Dienogest in a modified relea...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-006633-41

Monocenter, open-label, randomized study to determine the ovulation inhibitory effect of the combined oral contraceptives SH T04769G (0.015 mg Ethinylestradiol and 1.5 mg Dienogest in a modified release medicinal product) and SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest), applied for two treatment cycles to 60 healthy female volunteers

Femme Homme

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Extrait

The aim of the study is to determine the ovulation inhibitory effect of the COC SH T04769G (0.015 mg Ethinylestradiol and 1.5 mg Dienogest in a modified release film-coated tablet) and to collect supplementary data regarding the ovulation inhibitory effect of SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest) in treatment cycle 2. Ovulation inhibition will be assessed by TVU of the leading follicle diameter and by analysis of serum hormone levels (estradiol, progesterone). Ovarian activity will be classified according to Hoogland & Skouby (1993). A score of < 6 will be regarded as inhibition of ovulation.

Critère d'inclusion

  • The aim of this monocenter, open-label, randomized study is to determine the ovulation inhibitory effect of the COC SH T04769G (0.15 mg Ethinylestradiol and 1.5 mg Dienogest in a modified release film-coated tablet) and to collect supplementary data regarding the ovulation inhibitory effect of the well-established COC Valette SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest). The intended indication for the product under development is the hormonal contraception

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