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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,921
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
Unnamed facility
Xiamen, Fujian, China
Number of subjects with adverse drug reactions (ADRs)
Time frame: 6 months
Number of unintended pregnancies as measured by the Pearl Index (PI)
Time frame: 6 months
Cycle control for subjects with and without proceeding abortion
Time frame: 6 months
Number of bleeding days
Time frame: Up to 90 days.
Number of bleeding episodes
Time frame: Up to 90 days.
Number of Acne lesions
Time frame: 6 months
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Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Shenzhen, Guangdong, China
Unnamed facility
Liuzhou, Guangxi, China
Unnamed facility
Nanning, Guangxi, China
Unnamed facility
Shijiazhuang, Hebei, China
Unnamed facility
Changshacun, Henan, China
Unnamed facility
Wuhan, Hubei, China
Unnamed facility
Yueyang, Hunan, China
...and 28 more locations