NCT02159261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2016

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

2.1 years

First QC Date

June 6, 2014

Last Update Submit

August 8, 2017

Conditions

Contraception

Keywords

Personal Satisfaction

Outcome Measures

Primary Outcomes (1)

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

    Up to 12 months

Secondary Outcomes (2)

  • 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

Study Arms (1)

Cohort 1

Female patients ≥ 18 years old requiring contraception.

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

Interventions

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

Patients treated by Physicians under approved local prescriptions

Cohort 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients ≥ 18 years old requiring contraception, treated with Yaz Plus for the first time and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Russia

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2014

First Posted

June 9, 2014

Study Start

July 15, 2014

Primary Completion

August 14, 2016

Study Completion

August 14, 2016

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

RU(1)