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

Condition(s) targeted: Contraception

Intervention: EE30/DRSP (Yasmin, BAY86-5131) (Drug); Any other OC (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling.

Secondary outcome:

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.

Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Many locations, Albania; Recruiting

Many Locations, Bahrain; Recruiting

Many locations, Egypt; Recruiting

Many locations, Hungary; Recruiting

Many Locations, Jordan; Recruiting

Many locations, Kenya; Terminated

Many Locations, Kuwait; Recruiting

Many Locations, Lebanon; Recruiting

Many locations, Macedonia, The Former Yugoslav Republic of; Recruiting

Many Locations, Oman; Recruiting

Many Locations, Qatar; Recruiting

Many Locations, Saudi Arabia; Recruiting

Many locations, United Arab Emirates; Recruiting

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Starting date: June 2009
Last updated: December 2, 2011