Trial Condition(s):
Contraception
Effects of counseling on the continuation rates and compliance for newly prescribed oral contraceptives (Yasmin® or any other oral contraceptives (OC)
Bayer Identifier:
14565
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many locations, United Arab Emirates | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Albania | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Egypt | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Hungary | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Kenya | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Macedonia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Saudi Arabia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kuwait | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Oman | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Jordan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Lebanon | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Bahrain | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Qatar | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Effects of counseling on the continuation rates and compliance for newly prescribed oral contraceptives (Yasmin® or any other oral contraceptives (OC))
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- 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 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.Timeframe: After 3 months and after approx. 6 months.
- Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.Timeframe: Over 12 months
Additional Information
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