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OpenTrials
Completed

NCT Number: NCT02159261

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

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.

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Key information

Conditions

Contraception Behavior Personal Satisfaction

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Russia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY98-7071_EE20/DRSP/L-5-MTHF

Drug

Patients treated by Physicians under approved local prescriptions

Primary outcomes

  1. Satisfaction measured with a Likert response scale (from 1 - poor to 5 - excellent)

    Time frame: Up to 12 months

Secondary outcomes

  1. Changes in EVAPIL scale for assessment of tolerability of oral contraceptives.

    Time frame: Baseline to 12 months

  2. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Prospective Multicenter Non-interventional Study on Patients and Physicians Satisfaction of Yaz Plus

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2014
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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