Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC))
Information source: Bayer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Yasmin (EE30/DR SP,BAY 86-5131). (Drug); Any other OC (Drug)
Phase: Phase 4
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
Summary
This study is a prospective, company-sponsored, non-interventional cohort study of up to
5000 patients in the following countries Albania, Bosnia and Herzegovina, Kenya, Macedonia,
Hungary, Middle East (Kingdom of Saudi Arabia, Gulf, Levant, Egypt), Moldova, Russia, Turkey
who are newly prescribed Yasmin or any other 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.
Clinical Details
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: Cohort, 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.
Eligibility
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.
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Many Locations, Saudi Arabia; Recruiting
Additional Information
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Starting date: May 2009
Ending date: April 2010
Last updated: October 19, 2009
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