Clinical trial NCT00905684: Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)
Official title: Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC))
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Compliance
Hormonal Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 5446
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


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.

Primary outcomes:
measure: Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling.
timeFrame: After 3 months and at end of study after approx. 6 months.
Secondary outcomes:
measure: 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.
timeFrame: After 3 months and after approx. 6 months.
measure: Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.
timeFrame: Over 12 months
Other outcomes:
Locations:
city: Many locations
country: Albania
city: Many Locations
country: Bahrain
city: Many locations
country: Egypt
city: Many locations
country: Hungary
city: Many Locations
country: Jordan
city: Many locations
country: Kenya
city: Many Locations
country: Kuwait
city: Many Locations
country: Lebanon
city: Many locations
country: Macedonia, The Former Yugoslav Republic of
city: Many Locations
country: Oman
city: Many Locations
country: Qatar
city: Many Locations
country: Saudi Arabia
city: Many locations
country: United Arab Emirates
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: