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临床试验/NCT01319500
NCT01319500已完成不适用

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

Center for Epidemiology and Health Research, Germany1 个研究点 分布在 1 个国家目标入组 3,776 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,776
试验地点
1
主要终点
OC Prescriptions by Treatment Group and Prescribing Medical Specialists

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

OC Prescriptions by Treatment Group and Prescribing Medical Specialists

时间窗: 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)

时间窗: February 2009 - March 2009

Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category "non-contraceptive reasons only"

Reasons for OC Prescriptions

时间窗: 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

时间窗: 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

时间窗: February 2009 - March 2009

Non-contraceptive reasons for OC prescriptions (including both categories: "contraception plus non-contraceptive reasons" and "non-contraceptive reasons only"

次要结局

未报告次要终点

研究者

发起方
Center for Epidemiology and Health Research, Germany
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juergen Dinger, MD, PhD

Principal Investigator

Center for Epidemiology and Health Research, Germany

研究点 (1)

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