A multicenter, double-blind, randomized trial on the bleeding profile of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.

ABSTRACT:

Purpose

A typical compliance problem in the use of traditional progestin-only pills is the irregular bleeding pattern and the strict daily intake. Desogestrel 75 mg has a 12-h missed-pill window; however, its poor cycle control limits a more common use.

Methods

A drospirenone (DRSP)-only pill was developed to improve the bleeding profile.

Setting

A phase III study in healthy women aged 18-45 years was performed to compare the bleeding profile and safety of a DRSP-only pill in a regime of 24 days of 4 mg of DRSP tablets followed by 4 days of placebo versus desogestrel 0.075 mg per day continuously over nine cycles.

Population

A total of 858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed.

Main outcome measures</

SUBMITTER: Palacios S 

PROVIDER: S-EPMC7174261 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature