Effects of Counseling on the Continuation Rates and Compl... | NCT00905684

Studies
Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)

NCT00905684

Sponsor

Bayer

Status

Completed

Last Update Posted

Mar 7, 2012Estimated

Enrollment

5,446Actual

Phase

Not provided

Conditions

Contraception

Interventions

EE30/DRSP (Yasmin, BAY86-5131)
Any other OC

Countries

Albania
Bahrain
Egypt
Hungary
Jordan
Kenya
Kuwait
Lebanon
North Macedonia
Oman
Qatar
Saudi Arabia
United Arab Emirates

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

ID	Type	Description	Link
YA0801	Other Identifier	Company internal

Status Module

Record Verification Date

Mar 2012

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

Jun 2009

Primary Completion Date

Not provided

Completion Date

Dec 2011Actual

First Submitted Date

May 18, 2009

First Submission Date that Met QC Criteria

May 19, 2009

First Posted Date

May 20, 2009Estimated

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

Mar 6, 2012

Last Update Posted Date

Mar 7, 2012Estimated

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

This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin or any other OC has been made. Physicians should consult the full prescribing information for the respective OC before enrolling patients and familiarize themselves with the safety information in the product package label.

Detailed Description

Not provided

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

5,446Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: EE30/DRSP (Yasmin, BAY86-5131)
Group 2			Drug: Any other OC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EE30/DRSP (Yasmin, BAY86-5131)	Drug	Patients under regular daily life treatment receiving Yasmin according to local drug information	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling.		After 3 months and at end of study after approx. 6 months.

Secondary Outcomes

Measure	Description	Time Frame
Analyses stratified by baseline factors such as age group, presence or absence of cycle disorders, and history of oral contraceptive method will be performed as well.		After 3 months and after approx. 6 months.
Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization
Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)

Exclusion Criteria:

The contraindications and warnings of the Summary of Product Characteristics must be followed.

Accepts Healthy Volunteers

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

Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Facility	Status	City	State	ZIP	Country	Contacts
		Many Locations			Albania

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior