check_circleStudy Completed

Hirsutism, Dermatitis, Seborrheic Alopecia, Severe Acne, Seborrhea

Bayer Identifier:

17194

ClinicalTrials.gov Identifier:

NCT02494297

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study on the Prescribing Indications for combinations of cyproterone acetate and ethinylestradiol in 5 European Countries

Trial purpose

This study is designed to compile the reasons and specific indications for the prescription of Cyproterone Acetate combined with Ethinyl Estradiol by Health Care Providers. The primary objective of the study is to characterize the prescribing behaviors for Cyproterone Acetate combined with Ethinyl Estradiol in 5 European countries (Austria, Czech Republic, France, the Netherlands, and Spain), including:

•prescription indications for Cyproterone Acetate combined with Ethinyl Estradiol
•use of Cyproterone Acetate combined with Ethinyl Estradiol in accordance with the updated label
•concomitant use of Cyproterone Acetate combined with Ethinyl Estradiol and combined hormonal contraceptives
•second line treatment with Cyproterone Acetate combined with Ethinyl Estradiol for the indication acne

Key Participants Requirements

Sex

Female

Age

NaN - N/A
  • - Women who are prescribed CPA/EE medication during the study period.
    - Women who are willing to participate in the drug utilization study
  • - Women who are not willing to sign the informed consent
    - Women with a language barrier

Trial summary

Enrollment Goal
1408
Trial Dates
March 2015 - May 2016
Phase
N/A
Could I Receive a placebo
No
Products
Diane 35 (EE/CPA, BAY86-5264)
Accepts Healthy Volunteer
No

Primary Outcome

  • Drug utilization pattern of CPA/EE
    date_rangeTime Frame:
    within 6 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Drug Utilization Study on the Prescribing Indications for CPA/EE in 5 European Countries
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer products.