Efficacy and safety of drospirenone as a progestin-only pill in Japanese women: A phase III study.

ABSTRACT:

Aim

To evaluate the efficacy and safety of 4 mg of drospirenone (DRSP), a progestin-only pill (POP), for contraception in Japanese women.

Methods

This was a multicenter, open-label, single-arm study. The dosing period of DRSP was 13 cycles, each lasting for 28 days. In one cycle, 4 mg of DRSP was administered orally once daily for the first 24 days, followed by a placebo for 4 days.

Results

Data from 276 subjects were analyzed, with a total of 3319 DRSP exposure cycles. Pregnancy occurred in one subject. The overall Pearl Index [95% CI] was 0.39 [0.01, 2.18], and the cumulative pregnancy rate [95% CI] was 0.40% [0.06, 2.81]. Of the 276 subjects, 273 (98.9%) experienced treatment-emergent adverse events (TEAEs) and 264 (95.7%) experienced adverse drug reactions. All TE

SUBMITTER: Kitamura K 

PROVIDER: S-EPMC12167661 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature