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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with an OC prescription during the timeframe (Feb-March 2011)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Yasmin<br>Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC Yasmin | |
| Other OCs<br>Users of OCs except Yasmin (Other OCs) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Reasons for OC Prescriptions by Gynecologists and Dermatologists |  | February 2009 - March 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Utilization, Oral Contraceptives