YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China
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|ClinicalTrials.gov Identifier: NCT02710708|
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : March 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: EE20/DRSP (YAZ, BAY86-5300)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1921 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 27, 2016|
|Actual Primary Completion Date :||July 3, 2018|
|Actual Study Completion Date :||July 3, 2018|
Experimental: Ethinyl Estradiol 20 (EE20)/DRSP (YAZ, BAY86-5300)
Chinese women between 18 and 45 years old inclusive (smokers not older than 35 years old) requesting oral contraception who have no contraindication to YAZ will be recruited for the study. Women who underwent surgical or medical abortions will also be recruited.
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
- 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 ]
- Severity of pain during menstruation measured by visual analog scale (VAS) [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710708
Show 38 Study Locations
|Study Director:||Bayer Study Director||Bayer|