ContraceptionNCT02159261
Assess Satisfaction of Patients and Physicians With Results of Yaz Plus Treatment for 13 Cycles
An observational study of Contraception, run by Bayer at 1 site in Russia.
Trial summary
Local prospective multicenter non-comparative non-interventional observational study. It's planed to assess satisfaction of patients and physicians with results of Yaz Plus treatment for 13 cycles in real practice. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- BAY98-7071_EE20/DRSP/L-5-MTHF
- How many people
- 1,500 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jul 2014to 14 Aug 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients ≥ 18 years old requiring contraception, treated with Yaz Plus for the first time and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.
Who may be able to join
- Female patients ≥ 18 years old
- Requiring contraception
- Prescribed with Yaz Plus for the first time
Who cannot join
- Contraindications for the use of Yaz Plus in accordance with the local product information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Non-interventional Study on Patients and Physicians Satisfaction of Yaz Plus
Local prospective multicenter non-comparative non-interventional observational study. It's planed to assess satisfaction of patients and physicians with results of Yaz Plus treatment for 13 cycles in real practice.
Read the detailed description
Non-interventional, Yaz Plus, Contraception, Assess satisfaction, Russian Federation.
- Conditions
- Contraception
- Being tested
- BAY98-7071_EE20/DRSP/L-5-MTHF
- Keywords
- Personal Satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY98-7071_EE20/DRSP/L-5-MTHFDrug
Patients treated by Physicians under approved local prescriptions
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Female patients ≥ 18 years old requiring contraception. Receives: Drug: BAY98-7071_EE20/DRSP/L-5-MTHF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction measured with a Likert response scale (from 1 - poor to 5 - excellent)
Measured: Up to 12 months
Secondary outcomes (2)
Changes in EVAPIL scale for assessment of tolerability of oral contraceptives.
Measured: Baseline to 12 months
Number of participants with adverse events as a measure of safety and tolerability
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study start15 Jul 2014
- Primary completion14 Aug 2016
- Study completion14 Aug 2016
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
- 1,500 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
- NCT02159261
- Sponsor's protocol ID
- 17177
- Other IDs
- YZ1410RU
- Status last verified
- Aug 2017
- First submitted
- 6 Jun 2014
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Non-interventional Study on Patients and Physicians Satisfaction of Yaz Plus
- ClinicalTrials.gov ID
- NCT02159261
- Acronym / sponsor ID
- 17177
- Conditions
- Contraception
- Keywords
- Personal Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2014 (actual)
- Primary completion
- 14 Aug 2016 (actual)
- Study completion
- 14 Aug 2016 (actual)
- First posted
- 9 Jun 2014 (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.
Local prospective multicenter non-comparative non-interventional observational study. It's planed to assess satisfaction of patients and physicians with results of Yaz Plus treatment for 13 cycles in real practice.
Detailed description
Non-interventional, Yaz Plus, Contraception, Assess satisfaction, Russian Federation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: BAY98-7071_EE20/DRSP/L-5-MTHFFemale patients ≥ 18 years old requiring contraception. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients ≥ 18 years old requiring contraception, treated with Yaz Plus for the first time and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.
Key inclusion criteria (3 listed)
- Female patients ≥ 18 years old
- Requiring contraception
- Prescribed with Yaz Plus for the first time
Key exclusion criteria (1 listed)
- Contraindications for the use of Yaz Plus in accordance with the local product information
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 |
|---|---|---|
| BAY98-7071_EE20/DRSP/L-5-MTHFPatients treated by Physicians under approved local prescriptions | Drug | Cohort 1 |
Primary outcome
Satisfaction measured with a Likert response scale (from 1 - poor to 5 - excellent)
Time frame: Up to 12 months
2 secondary outcomes
Changes in EVAPIL scale for assessment of tolerability of oral contraceptives.
Time frame: Baseline to 12 months
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 12 months
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 9 Aug 2017.
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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 Russia.
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 3 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 9 Aug 2017. 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 Russia. 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?
Satisfaction measured with a Likert response scale (from 1 - poor to 5 - excellent) (time frame: Up to 12 months). 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 9 Aug 2017.