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AzTrials

ContraceptionPhase 4NCT02710708

YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China

A Phase 4 study testing EE20/DRSP (YAZ, BAY86-5300) in people with Contraception, run by Bayer at 38 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Contraception
What is being tested?
EE20/DRSP (YAZ, BAY86-5300)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,921 participants
Where
38 sitesChina
Study dates
27 May 2016to 3 Jul 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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 locations and contacts

38 sites in 1 country.

38 sites in 1 country

China38 sites

  • Study site

    Beijing, 100026

  • Study site

    Beijing, 100029

  • Study site

    Beijing, 100034

  • Study site

    Beijing, 100038

  • Study site

    Beijing, 100123

  • Study site

    Beijing, 100191

  • Study site

    Beijing, 100853

  • Study site

    Changshacun, Henan

  • Study site

    Changzhou, Jiangsu, 213003

  • Study site

    Chengdu, Sichuan, 610091

  • Study site

    Guangzhou, Guangdong, 510405

  • Study site

    Guangzhou, Guangdong, 510623

  • Study site

    Hangzhou, Zhejiang, 310006

  • Study site

    Hangzhou, Zhejiang, 310016

  • Study site

    Hangzhou, Zhejiang

  • Study site

    Kunming, Yunnan, 650011

  • Study site

    Kunming, Yunnan, 650032

  • Study site

    Liuzhou, Guangxi, 545006

  • Study site

    Nanchang, Jiangxi, 330006

  • Study site

    Nanjing, Jiangsu, 210006

  • Study site

    Nanjing, Jiangsu, 210008

  • Study site

    Nanning, Guangxi, 530021

  • Study site

    Shanghai, 200040

  • Study site

    Shanghai, 200127

  • Study site

    Shenzhen, Guangdong, 518036

  • Study site

    Shijiazhuang, Hebei, 050035

  • Study site

    Taiyuan, Shanxi, 030001

  • Study site

    Tianjin, 300052

  • Study site

    Ürümqi, Xinjiang

  • Study site

    Weifang, Shandong, 261031

  • Study site

    Weifang, Shandong

  • Study site

    Wenzhou, Zhejiang, 325000

  • Study site

    Wuhan, Hubei, 430014

  • Study site

    Wuxi, Jiangsu, 214002

  • Study site

    Xi'an, Shaanxi, 710061

  • Study site

    Xiamen, Fujian

  • Study site

    Yueyang, Hunan, 414000

  • Study site

    Zibo, Shandong

Other trials in China

About this study

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

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.

Conditions
Contraception
Being tested
EE20/DRSP (YAZ, BAY86-5300)
Keywords
birth control,, contraceptives safety,, contraceptives efficacy,, moderate acne vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EE20/DRSP (YAZ, BAY86-5300)Drug

    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

Study groups in NCT02710708
Study groupRoleWhat they receive
Ethinyl Estradiol 20 (EE20)/DRSP (YAZ, BAY86-5300)ExperimentalChinese 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.
Receives: Drug: EE20/DRSP (YAZ, BAY86-5300)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with adverse drug reactions (ADRs)

    Measured: 6 months

Secondary outcomes (5)

  1. Number of unintended pregnancies as measured by the Pearl Index (PI)

    Measured: 6 months

  2. Cycle control for subjects with and without proceeding abortion

    Measured: 6 months

  3. Number of bleeding days

    Measured: Up to 90 days.

  4. Number of bleeding episodes

    Measured: Up to 90 days.

  5. Number of Acne lesions

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2016 (estimated)
  2. Study start27 May 2016
  3. Primary completion3 Jul 2018
  4. Study completion3 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,921 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02710708
Sponsor's protocol ID
18261
Status last verified
Jun 2019
First submitted
14 Mar 2016
Last updated
28 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31950432

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EE20/DRSP (YAZ, BAY86-5300) in people with Contraception, run by Bayer at 38 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with adverse drug reactions (ADRs) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02710708, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019; AzTrials last refreshed its copy on 27 Oct 2026.

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