Assess Satisfaction of Patients and Physicians With Results of Yaz Plus Treatment for 13 Cycles

Completed

• Conditions: Contraception
• Interventions: Drug: BAY98-7071_EE20/DRSP/L-5-MTHF

• Registration Number: NCT02159261
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Non-interventional, Yaz Plus, Contraception, Assess satisfaction, Russian Federation.

Study Timeline

• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-09
• Study Start: 2014-07-15
• Primary Completion: 2016-08-14
• Study Completion: 2016-08-14
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	BAY98-7071_EE20/DRSP/L-5-MTHF	Female patients ≥ 18 years old requiring contraception.

Primary Outcome Measures

Name	Time	Method
Satisfaction measured with a Likert response scale (from 1 - poor to 5 - excellent)	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Changes in EVAPIL scale for assessment of tolerability of oral contraceptives.	Baseline to 12 months
Number of participants with adverse events as a measure of safety and tolerability	Up to 12 months