Clinical trial NCT02710708: YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: birth control,
contraceptives safety,
contraceptives efficacy,
moderate acne vulgaris
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-03-17
Enrollment: 1921
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with adverse drug reactions (ADRs)
timeFrame: 6 months
Secondary outcomes:
measure: Number of unintended pregnancies as measured by the Pearl Index (PI)
timeFrame: 6 months
measure: Cycle control for subjects with and without proceeding abortion
timeFrame: 6 months
measure: Number of bleeding days
timeFrame: Up to 90 days.
measure: Number of bleeding episodes
timeFrame: Up to 90 days.
measure: Number of Acne lesions
timeFrame: 6 months
Other outcomes:
measure: Severity of pain during menstruation measured by visual analog scale (VAS)
timeFrame: 6 months
Locations:
city: Xiamen
country: China
state: Fujian
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Shenzhen
country: China
state: Guangdong
city: Liuzhou
country: China
state: Guangxi
city: Nanning
country: China
state: Guangxi
city: Shijiazhuang
country: China
state: Hebei
city: Changsha
country: China
state: Henan
city: Wuhan
country: China
state: Hubei
city: Yueyang
country: China
state: Hunan
city: Changzhou
country: China
state: Jiangsu
city: Nanjing
country: China
state: Jiangsu
city: Nanjing
country: China
state: Jiangsu
city: Wuxi
country: China
state: Jiangsu
city: Nanchang
country: China
state: Jiangxi
city: Xi'an
country: China
state: Shaanxi
city: Weifang
country: China
state: Shandong
city: Weifang
country: China
state: Shandong
city: Zibo
country: China
state: Shandong
city: Taiyuan
country: China
state: Shanxi
city: Chengdu
country: China
state: Sichuan
city: Urumchi
country: China
state: Xinjiang
city: Kunming
country: China
state: Yunnan
city: Kunming
country: China
state: Yunnan
city: Hangzhou
country: China
state: Zhejiang
city: Hangzhou
country: China
state: Zhejiang
city: Hangzhou
country: China
state: Zhejiang
city: Wenzhou
country: China
state: Zhejiang
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Tianjin
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.