Risk Minimisation Study for Diane-35 and Its Generics

NCT ID: NCT02410031

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

759 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-26

Study Completion Date

2016-03-04

Brief Summary

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The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist.

Specifically, the following objectives will be addressed:

* Investigate whether physicians have received any educational material related to Diane-35 or its generics
* Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card
* Assess physicians' knowledge and understanding of key safety information pertaining to the following areas:
* Contraindications relevant to thromboembolism
* Risk factors for thromboembolism
* Signs and symptoms of thromboembolism

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)

Prescribers of Diane-35 who agree and fulfill the criteria inclusion to participate in the survey

Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)

Intervention Type DRUG

Cyproterone acetate 2mg/ethinylestradiol 35 μg

Interventions

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Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)

Cyproterone acetate 2mg/ethinylestradiol 35 μg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-Physicians eligible to participate will have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RTI Health Solutions

OTHER

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Austria

Site Status

Many Locations, , Czechia

Site Status

Many Locations, , France

Site Status

Many Locations, , Netherlands

Site Status

Many Locations, , Spain

Site Status

Countries

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Austria Czechia France Netherlands Spain

Other Identifiers

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17195

Identifier Type: -

Identifier Source: org_study_id

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