check_circleStudy Completed
Contraception
Bayer Identifier:
18261
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
YAZ post authorization safety study (PASS)/post authorization efficacy study (PAES) in China
Trial purpose
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.
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.
Key Participants Requirements
Sex
FemaleAge
18 - 45 YearsTrial summary
Enrollment Goal
1921Trial Dates
May 2016 - July 2018Phase
Phase 4Could I Receive a placebo
NoProducts
YAZ (EE20/DRSP, BAY86-5300)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Shanghai, 200127, China | |
Completed | Urumchi, China | |
Completed | Guangzhou, 510623, China | |
Withdrawn | Shanghai, 200011, China | |
Completed | Kunming, 650032, China | |
Completed | Weifang, China | |
Completed | hangzhou, China | |
Withdrawn | Nanjing, 210009, China | |
Completed | Nanjing, 210006, China | |
Completed | Zibo, China | |
Withdrawn | Jinan, 250033, China | |
Completed | Beijing, 100191, China | |
Completed | Nanchang, 330006, China | |
Completed | Hangzhou, 310006, China | |
Completed | Beijing, 100853, China | |
Completed | Beijing, 100038, China | |
Completed | Beijing, 100034, China | |
Completed | Wenzhou, 325000, China | |
Withdrawn | Nanning, 530021, China | |
Completed | Changzhou, 213003, China | |
Withdrawn | Guangzhou, 510120, China | |
Completed | Xi'an, 710061, China | |
Completed | Hangzhou, 310016, China | |
Withdrawn | Wuhan, 430030, China | |
Completed | Changsha, China | |
Completed | Taiyuan, 030001, China | |
Completed | Xiamen, China | |
Completed | Shanghai, 200040, China | |
Completed | shijiazhuang, 050035, China | |
Completed | Beijing, 100029, China | |
Completed | Tianjin, 300052, China | |
Withdrawn | Nanjing, 210029, China | |
Completed | Nanjing, 210008, China | |
Completed | Wuxi, 214002, China | |
Completed | Wuhan, 430014, China | |
Withdrawn | Changchun, 130011, China | |
Completed | Liuzhou, 545006, China | |
Completed | Yueyang, 414000, China | |
Completed | Weifang, 261031, China | |
Completed | Chengdu, 610091, China | |
Completed | Kunming, 650011, China | |
Withdrawn | Shijiazhuang, 050051, China | |
Completed | Beijing, 100123, China | |
Completed | Taiyuan, 030001, China | |
Withdrawn | Guangzhou, 510080, China | |
Completed | Guangzhou, 510405, China | |
Withdrawn | Kunming, China | |
Completed | Nanning, 530021, China | |
Withdrawn | Dalian, 116011, China | |
Completed | Shenzhen, 518036, China | |
Withdrawn | Hangzhou, China | |
Withdrawn | Zhengzhou, China | |
Withdrawn | Zhengzhou, China | |
Withdrawn | Guangzhou, China | |
Withdrawn | Xi'an, China | |
Withdrawn | Jinan, China | |
Withdrawn | Liuzhou, China | |
Withdrawn | Yinchuan, 750004, China | |
Completed | Beijing, 100026, China |
Primary Outcome
- Number of subjects with adverse drug reactions (ADRs)date_rangeTime Frame:6 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Number of unintended pregnancies as measured by the Pearl Index (PI)date_rangeTime Frame:6 monthsenhanced_encryptionNoSafety Issue:
- Cycle control for subjects with and without proceeding abortiondate_rangeTime Frame:6 months
- Number of bleeding daysdate_rangeTime Frame:Up to 90 days.enhanced_encryptionNoSafety Issue:
- Number of bleeding episodesdate_rangeTime Frame:Up to 90 days.enhanced_encryptionNoSafety Issue:
- Number of Acne lesionsdate_rangeTime Frame:6 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1