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Completed

NCT Number: NCT00905684

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

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.

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Key information

Conditions

Contraception Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Albania

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EE30/DRSP (Yasmin, BAY86-5131)

Drug

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

Any other OC

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.

    Time frame: Over 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Study completion
2011
First posted
May 20, 2009
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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