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
1 other identifier
interventional
1,921
1 country
38
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2016
Typical duration for phase_4
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
March 17, 2016
CompletedStudy Start
First participant enrolled
May 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2018
CompletedJune 28, 2019
June 1, 2019
2.1 years
March 14, 2016
June 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with adverse drug reactions (ADRs)
6 months
Secondary Outcomes (5)
Number of unintended pregnancies as measured by the Pearl Index (PI)
6 months
Cycle control for subjects with and without proceeding abortion
6 months
Number of bleeding days
Up to 90 days.
Number of bleeding episodes
Up to 90 days.
Number of Acne lesions
6 months
Other Outcomes (1)
Severity of pain during menstruation measured by visual analog scale (VAS)
6 months
Study Arms (1)
Ethinyl Estradiol 20 (EE20)/DRSP (YAZ, BAY86-5300)
EXPERIMENTALChinese 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Signed and dated informed consent
- Chinese female subjects requesting oral contraception, including subjects who underwent abortion (medical or surgical)
- Planned use of combined oral contraceptives for at least 6 cycles
- Age: 18 to 45 years (inclusive); smokers must not be older than 35 years at the time of informed consent
- At least 4 weeks postpartum for women who are not breastfeeding or after a second trimester abortion
You may not qualify if:
- Evidence or suspicion of incomplete abortion (medical abortion subjects must have complete abortion confirmed by ultrasound \[endometrial thickness ≤ 15 mm\]).
- Pregnancy or lactation
- Menstrual disorders consistent with ovarian failure (eg, oligomenorrhea, amenorrhea, hypomenorrhea)
- Abuse of alcohol, drugs, or medicine (eg, laxatives)
- Inability to cooperate with the study procedures for any reason (eg, language comprehension, psychiatric illness, inability to get to the study site).
- Any diseases or conditions that can compromise the function of body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- Any contraindication to YAZ according to the Chinese label, such as:
- Renal impairment
- Adrenal insufficiency
- A high risk of arterial or venous thromboembolic diseases. Examples include subjects who are known to:
- Have deep vein thrombosis or pulmonary embolism, now or in the past
- Have cerebrovascular disease
- Have coronary artery disease
- Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (eg, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (38)
Unknown Facility
Xiamen, Fujian, China
Unknown Facility
Guangzhou, Guangdong, 510405, China
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Guangzhou, Guangdong, 510623, China
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Shenzhen, Guangdong, 518036, China
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Liuchow, Guangxi, 545006, China
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Nanning, Guangxi, 530021, China
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Shijiazhuang, Hebei, 050035, China
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Changshacun, Henan, China
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Wuhan, Hubei, 430014, China
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Yueyang, Hunan, 414000, China
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Changzhou, Jiangsu, 213003, China
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Nanjing, Jiangsu, 210006, China
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Nanjing, Jiangsu, 210008, China
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Wuxi, Jiangsu, 214002, China
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Nanchang, Jiangxi, 330006, China
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Xi'an, Shaanxi, 710061, China
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Weifang, Shandong, 261031, China
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Weifang, Shandong, China
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Zibo, Shandong, China
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Taiyuan, Shanxi, 030001, China
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Chengdu, Sichuan, 610091, China
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Ürümqi, Xinjiang, China
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Kunming, Yunnan, 650011, China
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Kunming, Yunnan, 650032, China
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Hangzhou, Zhejiang, 310006, China
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Hangzhou, Zhejiang, 310016, China
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Hangzhou, Zhejiang, China
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Wenzhou, Zhejiang, 325000, China
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Beijing, 100026, China
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Beijing, 100029, China
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Beijing, 100034, China
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Beijing, 100038, China
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Beijing, 100123, China
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Beijing, 100191, China
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Beijing, 100853, China
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Shanghai, 200040, China
Unknown Facility
Shanghai, 200127, China
Unknown Facility
Tianjin, 300052, China
Related Publications (1)
Sun X, Qian F, He Y, Gu X, Di W. Safety and Efficacy of Combined Oral Contraceptive Ethinyl Estradiol/Drospirenone (YAZ) in Chinese Women: A Single-Arm, Open-Label, Multicenter, Post-Authorization Study. Adv Ther. 2020 Feb;37(2):906-917. doi: 10.1007/s12325-019-01210-2. Epub 2020 Jan 16.
PMID: 31950432DERIVED
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2016
First Posted
March 17, 2016
Study Start
May 27, 2016
Primary Completion
July 3, 2018
Study Completion
July 3, 2018
Last Updated
June 28, 2019
Record last verified: 2019-06