YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China

Phase 4 Completed 1921 enrolled Bayer

NaSingle-groupOpen-labelTreatment

Summary

The primary objective is to assess the safety profile of YAZ in Chinese women, including adverse drug reactions (ADRs). The secondary objectives are to investigate the rate of unintended pregnancies, the cycle control for subjects with and without preceding abortion, the bleeding pattern of subjects with and without preceding abortion (including the abortion-related bleeding pattern) and the efficacy in moderate acne vulgaris. Another objective is to investigate the effect on dysmenorrhea.

Timeline

Start: 2016-05-27
Primary completion: 2018-07-03
Completion: 2018-07-03

Publications

Sun X, Qian F, He Y, Gu X, Di W. Safety and Efficacy of Combined Oral Contraceptive Ethinyl Estradiol/Drospirenone (YAZ) in Chinese Women: A Single-Arm, Open-Label, Multicenter, Post-Authorization Study. Adv Ther. 2020 Feb;37(2):906-917. doi: 10.1007/s12325-019-01210-2. Epub 2020 Jan 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	drospirenone	Unknown	3 mg	Oral
Subject	ethinyl estradiol	Small molecule	20 ug	Oral

Indications

No indication recorded.