NCT01319500

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,776

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2011

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 20, 2012

Completed
Last Updated

November 20, 2012

Status Verified

October 1, 2012

First QC Date

March 18, 2011

Results QC Date

August 15, 2012

Last Update Submit

October 17, 2012

Conditions

Contraception

Keywords

Drug UtilizationOral Contraceptives

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Yasmin

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

Other OCs

Users of OCs except Yasmin ("Other OCs")

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Epidemiology and Health Research Berlin

Berlin, 10115, Germany

Location

Results Point of Contact

Title
Dr Juergen Dinger
Organization
Center for Epidemiology and Health Research Berlin
dinger@zeg-berlin.de
+49 (0)30 945 10145

Study Officials

  • Juergen C Dinger, MD, PhD

    Berlin Center for Epidemiology and Health Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2011

First Posted

March 21, 2011

Study Start

February 1, 2009

Last Updated

November 20, 2012

Results First Posted

November 20, 2012

Record last verified: 2012-10

Locations

DE(1)