To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
955
Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days)
Unnamed facility
Guangzhou, Guangdong, China
Number of unintended pregnancies
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
Number of expected bleeding days
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
Number of unexpected bleeding days
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
Number of expected bleeding episodes
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
Number of unexpected bleeding episodes
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to Cycle 13 (1 Cycle = 28 days)
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Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Shijiazhuang, Hebei, China
Unnamed facility
Wuhan, Hubei, China
Unnamed facility
Wuhan, Hubei, China
Unnamed facility
Changsha, Hunan, China
Unnamed facility
Hengyang, Hunan, China
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Dalian, Liaoning, China
Unnamed facility
Shenyang, Liaoning, China
...and 29 more locations