ContraceptionNCT00923572
Yasmin Post Marketing Surveillance
An observational study of Contraception, 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 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- EE30/DRSP (Yasmin, BAY86-5131)
- How many people
- 777 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2007to Aug 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Korean women who need oral contraceptive
Who may be able to join
- Women who need oral contraceptive
Who cannot join
- Patient who belongs to contraindication listed on the product label.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yasmin Regulatory Post Marketing Surveillance
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
- Conditions
- Contraception
- Being tested
- EE30/DRSP (Yasmin, BAY86-5131)
- Keywords
- Oral contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE30/DRSP (Yasmin, BAY86-5131)Drug
Patients in daily life clinical practice treatment receiving Yasmin according to indication on the label.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: EE30/DRSP (Yasmin, BAY86-5131) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy in real practice
Measured: After 6 cycle of treatment
Secondary outcomes (5)
Demography
Measured: At initial visit
Medical History
Measured: At initial visit
Administration period of Yasmin
Measured: After 6 cycle of treatment or at the point of withdrawan
Patient's compliance
Measured: After 6 cycle of treatment or at the point of withdrawan
Adverse Event / Serious AE collection
Measured: At point of the occurence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startDec 2007
- Primary completionMay 2013
- Study completionAug 2013
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
- 777 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
- NCT00923572
- Sponsor's protocol ID
- 14339
- Other IDs
- YA0510KR
- Status last verified
- Nov 2015
- First submitted
- 17 Jun 2009
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yasmin Regulatory Post Marketing Surveillance
- ClinicalTrials.gov ID
- NCT00923572
- Acronym / sponsor ID
- 14339
- Conditions
- Contraception
- Keywords
- Oral contraceptive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 777 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Jun 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: EE30/DRSP (Yasmin, BAY86-5131) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean women who need oral contraceptive
Key inclusion criteria (1 listed)
- Women who need oral contraceptive
Key exclusion criteria (1 listed)
- Patient who belongs to contraindication listed on the product label.
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 |
|---|---|---|
| EE30/DRSP (Yasmin, BAY86-5131)Patients in daily life clinical practice treatment receiving Yasmin according to indication on the label. | Drug | Group 1 |
Primary outcome
Safety and efficacy in real practice
Time frame: After 6 cycle of treatment
5 secondary outcomes
Demography
Time frame: At initial visit
Medical History
Time frame: At initial visit
Administration period of Yasmin
Time frame: After 6 cycle of treatment or at the point of withdrawan
Patient's compliance
Time frame: After 6 cycle of treatment or at the point of withdrawan
Adverse Event / Serious AE collection
Time frame: At point of the occurence
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 11 Nov 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, 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 1 inclusion and 1 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 11 Nov 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?
Safety and efficacy in real practice (time frame: After 6 cycle of treatment). 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 11 Nov 2015.