NCT02710708

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

Single-arm, Open-label, Interventional Study to Observe the Safety and Efficacy Profile of the Combined Oral Contraceptive YAZ®, a 24-day Cyclic Regimen Containing Drospirenone 3 mg and Ethinyl Estradiol 20 µg During a Treatment Duration of 6 Cycles: a Post-authorization Safety and Efficacy Study in Chinese Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,921 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	EE20/DRSP (YAZ, BAY86-5300)	YAZ (DRSP 3 mg/EE 20 µg), oral route, 6 cycles of 28 days per cycle, each cycle comprising 24 days of active tablets followed by 4 days of placebo tablets

Timeline

• Start date: 2016-05-27
• Primary completion: 2018-07-03
• Completion: 2018-07-03
• First posted: 2016-03-17
• Last updated: 2019-06-28

Locations

38 sites across 1 country: China