Assess Satisfaction of Patients and Physicians With Resul... | NCT02159261

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

NCT02159261

Sponsor

Bayer

Status

Completed

Last Update Posted

Aug 9, 2017Actual

Enrollment

1,500Actual

Phase

Not provided

Conditions

Contraception

Interventions

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

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
YZ1410RU	Other Identifier	Company Internal

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2014Actual

Primary Completion Date

Aug 14, 2016Actual

Completion Date

Aug 14, 2016Actual

First Submitted Date

Jun 6, 2014

First Submission Date that Met QC Criteria

Jun 6, 2014

First Posted Date

Jun 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2017

Last Update Posted Date

Aug 9, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1		Female patients ≥ 18 years old requiring contraception.	Drug: BAY98-7071_EE20/DRSP/L-5-MTHF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BAY98-7071_EE20/DRSP/L-5-MTHF	Drug	Patients treated by Physicians under approved local prescriptions	Cohort 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample