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

NCT00905684 | Completed

• 2 other identifiers: 14565YA0801
• Study Type: observational
• Target: 5,446
• Locations: 13 countries
• Sites: 13

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.

Conditions

Contraception

Keywords

Compliance; Hormonal Contraception

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• 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.

  Over 12 months

Study Arms (2)

Group 1

Drug: EE30/DRSP (Yasmin, BAY86-5131)

Group 2

Drug: Any other OC

Interventions

EE30/DRSP (Yasmin, BAY86-5131) DRUG

Patients under regular daily life treatment receiving Yasmin according to local drug information

Group 1

Any other OC DRUG

Patients under regular daily life treatment receiving any other OC according to local drug information

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (13)

Unknown Facility

Many Locations, Albania

Location

Unknown Facility

Many Locations, Bahrain

Location

Unknown Facility

Many Locations, Egypt

Location

Unknown Facility

Many Locations, Hungary

Location

Unknown Facility

Many Locations, Jordan

Location

Unknown Facility

Many Locations, Kenya

Location

Unknown Facility

Many Locations, Kuwait

Location

Unknown Facility

Many Locations, Lebanon

Location

Unknown Facility

Many Locations, North Macedonia

Location

Unknown Facility

Many Locations, Oman

Location

Unknown Facility

Many Locations, Qatar

Location

Unknown Facility

Many Locations, Saudi Arabia

Location

Unknown Facility

Many Locations, United Arab Emirates

Location

MeSH Terms

Conditions

Patient Compliance

Interventions

drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: June 1, 2009
• Study Completion: December 1, 2011
• Last Updated: March 7, 2012

Record last verified: 2012-03

Locations

EG (1); HU (1); QA (1); LE (1); OM (1); SA (1); AE (1); NO (1); AL (1); JO (1); BA (1); KE (1); KU (1)