ContraceptionPhase 3NCT00819312
YAZ, Oral Contraceptive Registration in China
A Phase 3 study testing YAZ (SH T00186, BAY86-5300) in people with Contraception, run by Bayer at 17 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- YAZ (SH T00186, BAY86-5300)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Dec 2008to Jan 2011
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women between 18 and 45 requesting oral contraception.
- Smokers may not exceed 30 years of age.
Who cannot join
- The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study.
- Pregnancy, lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment)
- Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea
- Any disease or condition that may worsen under hormonal treatment
- Other contraceptive methods such as sterilization or IUD/IUS
- Substantial overweight (BMI > 30 kg/m2).
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
China16 sites
Study site
Beijing, 100034
Study site
Beijing, 100044
Study site
Chengdu, Sichuan
Study site
Chongqing, 400010
Study site
Chongqing
Study site
Guangzhou, Guangdong, 510120
Study site
Guangzhou, Guangdong
Study site
Jinan, Shandong
Study site
Nanjing, Jiangsu, 210006
Study site
Nanjing, Jiangsu, 210009
Study site
Shanghai, 200011
Study site
Shanghai, 200127
Study site
Shenyang, Liaoning, 110004
Study site
Wuhan, Hubei, 430022
Study site
Xi’an, Shanxi, 710032
Study site
Yangzhou, Jiangsu, 225001
About this study
Official title: A Multicenter, Open-label, Single-arm Study to Investigate the Efficacy and Safety of the Oral Contraceptive YAZ (20 μg Ethinylestradiol, 3 mg Drospirenone) for 13 Cycles in 670 Healthy Chinese Female Volunteers.
The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.
- Conditions
- Contraception
- Being tested
- YAZ (SH T00186, BAY86-5300)
- Keywords
- Contraceptives,, Oral Hormonal;, Contraceptive Methods;, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YAZ (SH T00186, BAY86-5300)Drug
20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: YAZ (SH T00186, BAY86-5300) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment.
Measured: 13 cycles (1 cycle= 28 days)
Secondary outcomes (4)
Bleeding pattern indices
Measured: 13 cycles
Cycle control parameters
Measured: 13 cycles
Adverse events
Measured: Whole study period
Laboratory tests
Measured: Whole study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819312
- Sponsor's protocol ID
- 91619
- Other IDs
- 311041
- Status last verified
- Jan 2013
- First submitted
- 5 Jan 2009
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm Study to Investigate the Efficacy and Safety of the Oral Contraceptive YAZ (20 μg Ethinylestradiol, 3 mg Drospirenone) for 13 Cycles in 670 Healthy Chinese Female Volunteers.
- ClinicalTrials.gov ID
- NCT00819312
- Acronym / sponsor ID
- 91619
- Conditions
- Contraception
- Keywords
- Contraceptives,, Oral Hormonal;, Contraceptive Methods;, Female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive YAZ in healthy Chinese women.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: YAZ (SH T00186, BAY86-5300) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women between 18 and 45 requesting oral contraception.
- Smokers may not exceed 30 years of age.
Key exclusion criteria (6 listed)
- The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study.
- Pregnancy, lactation (less than 3 menstrual cycles since delivery, abortion or lactation before start of treatment)
- Menstrual disorders suspicious of ovarian failure (e.g. oligomenorrhea, amenorrhea, hypomenorrhea
- Any disease or condition that may worsen under hormonal treatment
- Other contraceptive methods such as sterilization or IUD/IUS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YAZ (SH T00186, BAY86-5300)20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd | Drug | Arm 1 |
Primary outcome
The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment.
Time frame: 13 cycles (1 cycle= 28 days)
4 secondary outcomes
Bleeding pattern indices
Time frame: 13 cycles
Cycle control parameters
Time frame: 13 cycles
Adverse events
Time frame: Whole study period
Laboratory tests
Time frame: Whole study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
Related trials for Contraception
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YAZ (SH T00186, BAY86-5300) in people with Contraception, run by Bayer at 17 sites in 2 countries.
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 2 inclusion and 6 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 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China, Hong Kong. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment. (time frame: 13 cycles (1 cycle= 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2013.