Who is sponsoring NCT00819312?

NCT00819312 is sponsored by Bayer.

What condition does NCT00819312 study?

NCT00819312 studies Contraception.

What drugs are being tested in NCT00819312?

Interventions: YAZ (SH T00186, BAY86-5300).

What is the status of NCT00819312?

NCT00819312 is currently COMPLETED.

Last reviewed 2013-01-27 · How we verify

A Multicenter, Open-label, Single-arm Study to Investigate the Efficacy and Safety of the Oral Contraceptive YAZ (20 μg Ethinylestradiol, 3 mg Drospirenone) for 13 Cycles in 670 Healthy Chinese Female Volunteers.

NCT00819312 Phase 3 COMPLETED

The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.

Details

Lead sponsor	Bayer
Phase	Phase 3
Status	COMPLETED
Enrolment	675
Start date	2008-12
Completion	2011-01

Conditions

Contraception

Interventions

YAZ (SH T00186, BAY86-5300)

Primary outcomes

The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment. — 13 cycles (1 cycle= 28 days)

Countries

China, Hong Kong