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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00905684

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.

Condition	Intervention
Contraception	Drug: EE30/DRSP (Yasmin, BAY86-5131) Drug: Any other OC

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC))

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling. [ Time Frame: After 3 months and at end of study after approx. 6 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: After 3 months and after approx. 6 months. ] [ Designated as safety issue: No ]
Special attention will be paid to serious adverse events and unexpected or unlisted ADRs. [ Time Frame: Over 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	8450
Study Start Date:	June 2009
Estimated Study Completion Date:	March 2012

Groups/Cohorts	Assigned Interventions
Group 1	Drug: EE30/DRSP (Yasmin, BAY86-5131) Patients under regular daily life treatment receiving Yasmin according to local drug information
Group 2	Drug: Any other OC Patients under regular daily life treatment receiving any other OC according to local drug information

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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)

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905684

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

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

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00905684 History of Changes
Other Study ID Numbers:	14565, YA0801
Study First Received:	May 18, 2009
Last Updated:	February 6, 2012
Health Authority:	Albania: Ministry of Health Department of Pharmacy; Macedonia: Ministry of Health; Hungary: National Institute of Pharmacy; Jordan: Ethical Committee; Lebanon: Institutional Review Board

Keywords provided by Bayer:

Compliance
Hormonal Contraception

Additional relevant MeSH terms:

Contraceptive Agents
Contraceptives, Oral
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on February 09, 2012