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

October 17, 2012 updated by: Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

3776

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Center for Epidemiology and Health Research Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Overall, a representative sample of 100 gynecologists and 31 dermatologists are asked to contribute OC prescribing data to this study.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Yasmin
Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC "Yasmin"
Other OCs
Users of OCs except Yasmin ("Other OCs")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OC Prescriptions by Treatment Group and Prescribing Medical Specialists
Time Frame: February 2009 - March 2009
Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists)
February 2009 - March 2009
Reasons for OC Prescriptions
Time Frame: February 2009 - March 2009
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
Time Frame: February 2009 - March 2009
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)
Time Frame: February 2009 - March 2009
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
Time Frame: February 2009 - March 2009
February 2009 - March 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Epidemiology and Health Research, Germany

Investigators

  • Principal Investigator: Juergen C Dinger, MD, PhD, Berlin Center for Epidemiology and Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

March 18, 2011

First Posted (Estimate)

March 21, 2011

Study Record Updates

Last Update Posted (Estimate)

November 20, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZEG 2009_02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraception

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe