Contraception Clinical Trial
Official title:
A Prospective Multicenter Non-interventional Study on Patients and Physicians Satisfaction of Yaz Plus
| Verified date | August 2017 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1500 |
| Est. completion date | August 14, 2016 |
| Est. primary completion date | August 14, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Female patients = 18 years old - Requiring contraception - Prescribed with Yaz Plus for the first time Exclusion Criteria: - Contraindications for the use of Yaz Plus in accordance with the local product information |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Satisfaction measured with a Likert response scale (from 1 - poor to 5 - excellent) | Up to 12 months | ||
| Secondary | Changes in EVAPIL scale for assessment of tolerability of oral contraceptives. | Baseline to 12 months | ||
| Secondary | Number of participants with adverse events as a measure of safety and tolerability | Up to 12 months |
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