check_circleStudy Completed

Contraception

Bayer Identifier:

14565

ClinicalTrials.gov Identifier:

NCT00905684

EudraCT Number:

Not Available

EU CT Number:

Not Available
Effects of counseling on the continuation rates and compliance for newly prescribed oral contraceptives (Yasmin® or any other oral contraceptives (OC)

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.

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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)

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

Trial summary

Enrollment Goal
8450
Trial Dates
June 2009 - December 2011
Phase
N/A
Could I Receive a placebo
No
Products
Yasmin (EE30/DRSP, BAY86-5131)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, United Arab Emirates
Completed
Many locations, Albania
Completed
Many locations, Egypt
Completed
Many locations, Hungary
Terminated
Many locations, Kenya
Completed
Many locations, Macedonia
Completed
Many Locations, Saudi Arabia
Completed
Many Locations, Kuwait
Completed
Many Locations, Oman
Completed
Many Locations, Jordan
Completed
Many Locations, Lebanon
Completed
Many Locations, Bahrain
Completed
Many Locations, Qatar

Primary Outcome

  • Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling.
    date_rangeTime Frame:
    After 3 months and at end of study after approx. 6 months.
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    Safety Issue:
    No

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.
    date_rangeTime Frame:
    After 3 months and after approx. 6 months.
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    Safety Issue:
    No
  • Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.
    date_rangeTime Frame:
    Over 12 months
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    Safety Issue:
    Yes

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
N/A

Additional Information

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