check_circleStudy Completed

Contraception

Bayer Identifier:

18261

ClinicalTrials.gov Identifier:

NCT02710708

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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - 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
  • - 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)
     --- 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

Trial summary

Enrollment Goal
1921
Trial Dates
May 2016 - July 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of unintended pregnancies as measured by the Pearl Index (PI)
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    No
  • Cycle control for subjects with and without proceeding abortion
    date_rangeTime Frame:
    6 months
  • Number of bleeding days
    date_rangeTime Frame:
    Up to 90 days.
    enhanced_encryption
    Safety Issue:
    No
  • Number of bleeding episodes
    date_rangeTime Frame:
    Up to 90 days.
    enhanced_encryption
    Safety Issue:
    No
  • Number of Acne lesions
    date_rangeTime Frame:
    6 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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