ContraceptionNCT00998257
Regulatory Post Marketing Surveillance Study on YAZ
An observational study of Contraception and Premenstrual Syndrome, run by Bayer at 1 site in South Korea.
Trial summary
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Contraception, Premenstrual Syndrome, Acne
- What is being tested?
- EE20/DRSP (YAZ, BAY86-5300)
- How many people
- 770 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2009to Nov 2011
- Phase
- Observational
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Korean female who need only contraception or contraception and management of PMDD or contraception and treatment of acne.
Who may be able to join
- Healthy female subjects
- requesting contraception
- suggesting PMDD by Physician who are also requesting contraception
- with acne who are also requesting contraception
- Age: 18 - 50 years
- Women who is prescribed YAZ first, during study period
Who cannot join
- Women who are contraindicated based on the label of YAZ
- Presence or a history of venous or arterial thrombotic/ thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
- Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)
- History of migraine with focal neurological symptoms
- Diabetes mellitus with vascular involvement
- The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication
Show all 14Show fewer
- Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
- Presence or history of severe hepatic disease as long as liver function values have not returned to normal
- Severe renal insufficiency or acute renal failure
- Presence or history of liver tumours (benign or malignant)
- Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)
- Undiagnosed vaginal bleeding
- Known or suspected pregnancy
- Hypersensitivity to the active substances or to any of the excipients
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
- Conditions
- Contraception, Premenstrual Syndrome, Acne
- Being tested
- EE20/DRSP (YAZ, BAY86-5300)
- Keywords
- Contraception, Premenstrual Dysphoric Disorder, PMDD, Acne
- Medical subject headings
- Premenstrual Syndrome, Acne Vulgaris, Premenstrual Dysphoric Disorder
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
Patients under daily life treatment with YAZ according to local drug information.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: EE20/DRSP (YAZ, BAY86-5300) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event collection
Measured: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Contraception efficacy
Measured: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Drug compliance
Measured: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Release of Premenstrual Dysphoric Disorder (PMDD) or acne
Measured: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Secondary outcomes (3)
Number of patients who used YAZ just for contraception
Measured: At initial visit (Day 0)
Number of patients who used YAZ for PMDD + contraception
Measured: At initial visit (Day 0)
Number of patients who used YAZ for Acne + contraception
Measured: At initial visit (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2011
- Study completionNov 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998257
- Sponsor's protocol ID
- 14785
- Other IDs
- YA0910KR, YAZ rPMS
- Status last verified
- Jan 2015
- First submitted
- 21 Sep 2009
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Post Marketing Surveillance Study on YAZ
- ClinicalTrials.gov ID
- NCT00998257
- Acronym / sponsor ID
- 14785
- Conditions
- Contraception, Premenstrual Syndrome, Acne
- Keywords
- Contraception, Premenstrual Dysphoric Disorder, PMDD, Acne
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Oct 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 objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: EE20/DRSP (YAZ, BAY86-5300) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Korean female who need only contraception or contraception and management of PMDD or contraception and treatment of acne.
Key inclusion criteria (6 listed)
- Healthy female subjects
- Age: 18 - 50 years
- Women who is prescribed YAZ first, during study period
Key exclusion criteria (14 listed)
- Women who are contraindicated based on the label of YAZ
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 |
|---|---|---|
| EE20/DRSP (YAZ, BAY86-5300)Patients under daily life treatment with YAZ according to local drug information. | Drug | Group 1 |
Primary outcome
Adverse event collection
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Contraception efficacy
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Drug compliance
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Release of Premenstrual Dysphoric Disorder (PMDD) or acne
Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
3 secondary outcomes
Number of patients who used YAZ just for contraception
Time frame: At initial visit (Day 0)
Number of patients who used YAZ for PMDD + contraception
Time frame: At initial visit (Day 0)
Number of patients who used YAZ for Acne + contraception
Time frame: At initial visit (Day 0)
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 21 Jan 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Premenstrual Syndrome, run by Bayer at 1 site in South Korea.
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 6 inclusion and 14 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 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
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?
Adverse event collection (time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)). The study lists 4 primary outcomes in all. 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 21 Jan 2015.