A single-centre, Phase 2, open-label study to investigate ovulation inhibition after the administration of different dosages of dienogest tablets in combination with different dosages of drospirenone tablets with regular intake and after intentional intake errors in healthy premenopausal female participants

Condition studied

Contraception/Pregnancy prevention in healthy subjects

Investigational medicinal product(s)

Eligibility

Primary endpoint

Ovulation incidence in treatment cycles 1-3. Ovulation is defined as Hoogland-Skouby score (HSS) 5 or 6.

Endpoint detail

Ovulation incidence over treatment cycles 1, 2 and 3. Ovulation is defined as Hoogland-Skouby score (HSS) 5 or 6., Ovulation incidence over treatment cycles 1-2. Ovulation is defined as Hoogland-Skouby score (HSS) 5 or 6., • Hoogland-Skouby score determined over each treatment cycle • Participant-wise maximum Hoogland-Skouby score over treatment cycles 1-2 and over treatment cycles 1-3, Fulfilment of Landgren criterion in cycles with Hoogland-Skouby score 5 or 6, • FLS diameter and endometrial thickness determined by transvaginal ultrasound (TVUS) at each time point during treatment • Participant-wise maximum value of the FLS diameter and maximum endometrial thickness per treatment cycle, over treatment cycles 1-2 and over treatment cycles 1-3, • Serum concentrations of estradiol (E2) and progesterone (P) at each time point during treatment • Participant-wise maximum concentrations of E2 and P per treatment cycle, over treatment cycles 1-2 and over treatment cycles 1-3 • Participant-wise mean concentrations of E2 per treatment cycle, over treatment cycles 1-2 and over treatment cycles 1-3 • Treatment group-wise mean and median concentrations of E2 and P per treatment cycle, over treatment cycles 1-2 and over treatment cycles 1-3, • Plasma conc. of DNG & DRSP det. (sparse PK sampl. indep. of tab. intake time) • Trough plasma conc. of DNG & DRSP, for which blood samples are taken as follows: o on one visit during TC 1 (after D6) & on one visit during TC 2; 24 ± 1.5h after the last tab. intake & within 5 min. before the current tablet intake o on det. days during TC 3, 24 ± 1.5h after the last tab. intake o on det. days during TC 3, 48 ± 1.5h after the last tab. intake & within 5 min. before the sched. double dose intake, • Tot. no. of bleed./spot. eps. in TC 1-3 • Tot. no. of days of bleed./spot., bleed. only & spot. only in TC 1-3, TC 1-2, TC 1, 2 & 3 • Prop. of wmn with bleed./spot., bleed. only, spot. only in TC 1-3 (excl. the first 7 TD) • Prop. of wmn with bleed./spot., bleed. only, spot. only in TC 1-2 (excl. the first 7 TD) • Prop. of wmn with bleed./spot., bleed. only, spot. only per TC 1 (excl. the first 7 TD), 2 & 3 • Prop. of light, usual & heavy bleed. days per TC 1, 2 & 3, • Adverse Events • Safety clinical laboratory parameters