Trial Condition(s):
Contraception
Assess satisfaction of patients and physicians with results of Yaz Plus treatment for 13 cycles
Bayer Identifier:
17177
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
1500
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
BEYAZ (EE20/DRSP/L-5-MTHF, BAY98-7071)
Accepts Healthy Volunteers
Yes
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Russia | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A prospective multicenter non-interventional study on patients and physicians satisfaction of Yaz Plus
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Satisfaction measured with a Likert response scale (from 1 – poor to 5 – excellent)Timeframe: Up to 12 months
Secondary Outcome
- Changes in EVAPIL scale for assessment of tolerability of oral contraceptives.Timeframe: Baseline to 12 months
- Number of participants with adverse events as a measure of safety and tolerabilityTimeframe: Up to 12 months
Additional Information
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