NCT02410031

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

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

Enrollment
759

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
5 countries

5 active sites

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

First Submitted

Initial submission to the registry

April 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 26, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2016

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

April 2, 2015

Last Update Submit

April 4, 2017

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • The knowledge of the physician concerning Diane-35

    The knowledge will be assessed based on a questionnaire with 22 questions which wil assess physician knowledge on key information contained in the Diane-35 educational material including patient information card, prescribers' checklist

    Day1

Study Arms (1)

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

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

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

Interventions

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

Cyproterone acetate 2mg/ethinylestradiol 35 μg

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Many Locations, Austria

Location

Unknown Facility

Many Locations, Czechia

Location

Unknown Facility

Many Locations, France

Location

Unknown Facility

Many Locations, Netherlands

Location

Unknown Facility

Many Locations, Spain

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Cyproterone AcetateEthinyl EstradiolCyproterone acetate, ethinyl estradiol drug combination

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

CyproteronePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, ChlorinatedNorpregnatrienesNorpregnanesNorsteroidsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 7, 2015

Study Start

June 26, 2015

Primary Completion

March 4, 2016

Study Completion

March 4, 2016

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

CZ(1)ES(1)AU(1)FR(1)NL(1)