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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3776 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

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.

Conditions

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Contraception

Keywords

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Drug Utilization Oral Contraceptives

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Yasmin

Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC "Yasmin"

No interventions assigned to this group

Other OCs

Users of OCs except Yasmin ("Other OCs")

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Juergen Dinger, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juergen C Dinger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Berlin Center for Epidemiology and Health Research

Locations

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Center for Epidemiology and Health Research Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ZEG 2009_02

Identifier Type: -

Identifier Source: org_study_id