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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319500
• Other study ID #: ZEG 2009_02
• Status: Completed
• Phase: N/A
• First received: March 18, 2011
• Last updated: October 17, 2012
• Start date: February 2009

Study information

• Verified date: October 2012
• Source: Center for Epidemiology and Health Research, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Croatian Health Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3776
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Contraception

Locations

Country	Name	City	State
Germany	Center for Epidemiology and Health Research Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Center for Epidemiology and Health Research, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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