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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00905684

Enrollment

5446

Registered

2009-05-20

Start date

2009-06-30

Completion date

2011-12-31

Last updated

2012-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Compliance, Hormonal Contraception

Brief 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.

Interventions

DRUGEE30/DRSP (Yasmin, BAY86-5131)

Patients under regular daily life treatment receiving Yasmin according to local drug information

DRUGAny other OC

Patients under regular daily life treatment receiving any other OC according to local drug information

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.

Secondary

Measure	Time frame
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.
Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.	Over 12 months

Countries

Albania, Bahrain, Egypt, Hungary, Jordan, Kenya, Kuwait, Lebanon, North Macedonia, Oman, Qatar, Saudi Arabia, United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026