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 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.

Condition	Intervention	Phase
Contraception	Drug: Yasmin (EE30/DR SP,BAY 86-5131). Drug: Any other OC	Phase IV

Study Type:	Observational
Study Design:	Cohort, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

n.a

Estimated Enrollment:	3000
Study Start Date:	May 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: Yasmin (EE30/DR SP,BAY 86-5131). 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:	Yes
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
	Not yet recruiting
Many Locations, Albania
Egypt
	Not yet recruiting
Many Locations, Egypt
Hungary
	Not yet recruiting
Many Locations, Hungary
Kenya
	Not yet recruiting
Many Locations, Kenya
Macedonia, The Former Yugoslav Republic of
	Not yet recruiting
Many Locations, Macedonia, The Former Yugoslav Republic of
Saudi Arabia
	Recruiting
Many Locations, Saudi Arabia
United Arab Emirates
	Not yet 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

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	14565, YA0801
Study First Received:	May 18, 2009
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00905684 History of Changes
Health Authority:	Albania: Ministry of Health Department of Pharmacy; Bosnia and Herzegovina: Federal Ministry of Health; Kenya: Ethical Review Committee; Macedonia: Ministry of Health; Hungary: National Institute of Pharmacy; Jordan: Ethical Committee; Lebanon: Institutional Review Board; Moldova: National Agency of Medicine; National Ethics Committee; Moldavia: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Russia: Ethics Committee; Turkey: Ethics Committee

Keywords provided by Bayer:

Compliance
Hormonal Contraception

Additional relevant MeSH terms:

Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptives, Oral

Contraceptive Agents, Female
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010