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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905684
• Other study ID #: 14565
• Secondary ID: YA0801
• Status: Completed
• Phase: N/A
• First received: May 18, 2009
• Last updated: March 6, 2012
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Albania: Ministry of Health Department of PharmacyMacedonia: Ministry of HealthHungary: National Institute of PharmacyJordan: Ethical CommitteeLebanon: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5446
• Est. completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• EE30/DRSP (Yasmin, BAY86-5131)
Patients under regular daily life treatment receiving Yasmin according to local drug information
• Any other OC
Patients under regular daily life treatment receiving any other OC according to local drug information

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Albania,  Bahrain,  Egypt,  Hungary,  Jordan,  Kenya,  Kuwait,  Lebanon,  Macedonia, The Former Yugoslav Republic of,  Oman,  Qatar,  Saudi Arabia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling.		After 3 months and at end of study after approx. 6 months.	No
Secondary	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.		After 3 months and after approx. 6 months.	No
Secondary	Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.		Over 12 months	Yes

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