Drug Utilization Study on the Prescribing Indications for Yasmin® and Other OCs in Croatia

Completed

• Conditions: Contraception

• Registration Number: NCT01319500
• Lead Sponsor: Center for Epidemiology and Health Research, Germany

Brief Summary

This study investigates the drug utilization pattern of Oral Contraceptives (OC) in Croatia. Gynecologists and Dermatologists were asked to contribute OC prescribing data to this study.

Detailed Description

Large, prospective non-interventional cohort studies with active surveillance of study participants indicate that many users of oral contraceptives use these preparations not only for contraception but also for the treatment of hormone-dependent diseases and symptoms - such as premenstrual dysphoric disorder, acne, endometriosis, ovarian cysts, polycystic ovary syndrome, bleeding disorders and painful periods. In the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS) more than 30% of participants reported that they use their OC for contra¬ception as well as for the treatment of one of the mentioned conditions.

It is also conceivable that some women use OC not for contraception but only for one of these hormone-dependent conditions. In most instances the exclusive use for these conditions would constitute off-label use as only few preparations have a stand-alone approved indication for one of these conditions.

For many countries the actual extent of off-label use of OCs for these conditions is unknown. This applies also to Croatia. Therefore, the Croatian health authority requested a drug utilization study to investigate current prescribing indications for Yasmin® and other OCs in Croatia. The study details were agreed upon with the Croatian health authority.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Results First Submitted: 2012-08-15
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-17
• Last Update Submitted: 2012-10-17
• Results First Posted: 2012-11-20
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3776

Inclusion Criteria

• women with an OC prescription during the timeframe (Feb-March 2011)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OC Prescriptions by Treatment Group and Prescribing Medical Specialists	February 2009 - March 2009	Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists)
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)	February 2009 - March 2009	Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category "non-contraceptive reasons only"
Reasons for OC Prescriptions	February 2009 - March 2009	The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only.
Reasons for OC Prescriptions by Gynecologists and Dermatologists	February 2009 - March 2009
Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for "Contraceptive and Non-contraceptive" and "Non-contraceptive Only" Reasons	February 2009 - March 2009	Non-contraceptive reasons for OC prescriptions (including both categories: "contraception plus non-contraceptive reasons" and "non-contraceptive reasons only"

Trial Locations

Locations (1)

Center for Epidemiology and Health Research Berlin; 🇩🇪 Berlin, Germany