DUS on the Prescribing Indications for CPA/EE in 5 European Countries

NCT02494297 | Completed Results

• 1 other identifier: ZEG2014_04
• Study Type: observational
• Target: 1,597
• Locations: 1 country
• Sites: 1

Brief Summary

This study was 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 was 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

Conditions

Hirsutism; Androgenetic Alopecia; Severe Anemia; Seborrhea; PCOS

Outcome Measures

Primary Outcomes (1)

• Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol

  Information was obtained from doctors prescribing CPA/EE. Categories in the Outcom Measure Data Table below are based on current disease status.

  within 18 months

Study Arms (1)

Cyproterone Acetate and Ethinyl Estradiol

Users of Diane 35 (EE/CPA, BAY86-5264)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who are prescribed Cyproterone Acetate combined with Ethinyl Estradiol during the study period

You may qualify if:

• Women who are prescribed Cyproterone Acetate combined with Ethinyl Estradiol during the study period
• Women who are willing to participate in the drug utilization study

You may not qualify if:

• Women who are not willing to sign the informed consent
• Women with a language barrier

Sponsors & Collaborators

• Center for Epidemiology and Health Research, Germany: lead
• Bayer: collaborator

Study Sites (1)

Center of Epidemiology and Health Research

Berlin, 10115, Germany

Location

Related Links

• Clinical Study Synopsis from Bayer AG

MeSH Terms

Conditions

Hirsutism; Alopecia; Anemia; Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Virilism; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypotrichosis; Pathological Conditions, Anatomical; Hematologic Diseases; Hemic and Lymphatic Diseases; Dermatitis; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Limitations and Caveats

The data cannot indicate a difference in prescribing habits between participating and non-participating physicians. The information about previous treatments of acne is likely to be incomplete because of recall bias.

Results Point of Contact

• Title: Dr. Klaas Heinemann
• Organization: Center for Epidemiology and Health Research, Germany

k.heinemann@zeg-berlin.de

0049 (0) 30 945 101 20

Study Officials

• Klaas Heinemann, PhD, MD, MSc, MBA

  Center for Epidemiology and Health Research Berlin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 10, 2015
• Study Start: March 6, 2015
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: August 27, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)