Multicenter, Open-Label Trial to Assess the Safety and Tolerability of Drospirenone 4.0 mg Over 6 Cycles in Female Adolescents, With a 7-Cycle Extension Phase

To assess the safety, tolerability and bleeding patterns of drospirenone 4.0 mg.Study DesignA multicenter, open-label, safety trial in sexually-active adolescents aged 12-17 years for six 28-day treatment cycles (Core Phase) and an optional 7-13 cycle extension with administration of drospirenone 4.0 mg in a regimen of 24 active/4 placebo tablets.

Source: Contraception - February 19, 2020 Category: OBGYN Authors: Dan Apter, Enrico Colli, Kristina Gemzell Danielsson, Klaus Peters Tags: Original Research Article Source Type: research