Study 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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Products

YAZ (EE20/DRSP, BAY86-5300)

Accepts Healthy Volunteer

Where 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)
Time Frame:
6 months
Safety Issue:
Yes

Secondary Outcome

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

Additional Information

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