check_circleStudy Completed

Contraception

Bayer Identifier:

17177

ClinicalTrials.gov Identifier:

NCT02159261

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assess satisfaction of patients and physicians with results of Yaz Plus treatment for 13 cycles

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.

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - Female patients ≥ 18 years old
    - Requiring contraception
    - Prescribed with Yaz Plus for the first time

  • - Contraindications for the use of Yaz Plus in accordance with the local product information

Trial summary

Enrollment Goal
1500
Trial Dates
July 2014 - August 2016
Phase
N/A
Could I Receive a placebo
No
Products
BEYAZ (EE20/DRSP/L-5-MTHF, BAY98-7071)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Russia

Primary Outcome

  • Satisfaction measured with a Likert response scale (from 1 – poor to 5 – excellent)
    date_rangeTime Frame:
    Up to 12 months
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    Safety Issue:
    No

Secondary Outcome

  • Changes in EVAPIL scale for assessment of tolerability of oral contraceptives.
    date_rangeTime Frame:
    Baseline to 12 months
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    Safety Issue:
    No
  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 12 months
    enhanced_encryption
    Safety Issue:
    Yes

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
N/A

Additional Information

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