YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China
NCT ID: NCT02710708
Last Updated: 2019-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
1921 participants
INTERVENTIONAL
2016-05-27
2018-07-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
YAZ, Oral Contraceptive Registration in China
NCT00819312
Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Relative to Yaz®
NCT06233071
Efficacy and Safety Oral Contraceptive Study
NCT00185484
GA YAZ ACNE in China Phase III
NCT00818519
Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ
NCT00567164
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* Have inherited or acquired hypercoagulopathies
* Have uncontrolled hypertension
* Have diabetes mellitus with vascular disease
* Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35
* Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
* Liver tumors, benign or malignant, or liver disease
* Hypersensitivity to any ingredient of the study drug
* Undiagnosed abnormal genital bleeding
* Sterilized subjects or concomitant use of other hormonal contraception, intrauterine device (IUD), or intrauterine system (IUS) during the study
* For subjects qualifying for the moderate acne subgroup:
* Subjects with acne and atopy, comedonal acne or acne conglobata, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts
* Use of preparations that have an acne-inducing effect (eg, iodinated or bromated drugs, tuberculostatics, lithium, vitamin B1 \[\>1.5 mg daily\], B6 \[\>2 mg daily\], B12 \[\>6 µg daily\], corticoids, adrenocorticotropic hormone anabolics, quinine, disulfiram, methoxypsoralene, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics)
* Subjects undergoing systemic acne treatment
18 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Shenzhen, Guangdong, China
Liuzhou, Guangxi, China
Nanning, Guangxi, China
Shijiazhuang, Hebei, China
Changshacun, Henan, China
Wuhan, Hubei, China
Yueyang, Hunan, China
Changzhou, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Wuxi, Jiangsu, China
Nanchang, Jiangxi, China
Xi'an, Shaanxi, China
Weifang, Shandong, China
Weifang, Shandong, China
Zibo, Shandong, China
Taiyuan, Shanxi, China
Chengdu, Sichuan, China
Ürümqi, Xinjiang, China
Kunming, Yunnan, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
Tianjin, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Click here to find results for studies related to Bayer products.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18261
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.