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Drug Utilization Study on the Prescribing Indications for Cyproterone Acetate and Ethinyl Estradiol in 5 European Countries

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ClinicalTrials.gov Identifier: NCT02494297
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : November 3, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Center for Epidemiology and Health Research, Germany

Brief Summary:

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

Condition or disease
Hirsutism Seborrheic Alopecia Severe Acne Seborrhea

Detailed Description:

Cyproterone acetate (CPA) 2mg, in combination with ethinyl estradiol (EE) 35mcg, is a medicinal product currently indicated for the treatment of moderate to severe acne in women of reproductive age. Due to the combination with ethinyl estradiol and the dosing, the preparations also act as effective contraceptives.

In 2012, the French health authority conducted a national review of Cyproterone Acetate combined with Ethinyl Estradiol and highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only. This triggered an Urgent Union Procedure at the beginning of 2013. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of Cyproterone Acetate combined with Ethinyl Estradiol (cyproterone acetate 2mg / ethinyl estradiol 35mcg) outweigh the risks, providing that several measures are taken to minimize the risk of thromboembolism. These medicines should be used solely for the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism in women of reproductive age. Since Cyproterone Acetate combined with Ethinyl Estradiol acts as a hormonal contraceptive, women should not take these medicines in combination with hormonal contraceptives. As one of the risk minimization measures, the Market Authorization Holders were required to conduct a number of studies including this drug utilization survey.

This study is a multi-national, cross sectional, prospective, non-interventional, drug utilization study conducted in 5 countries. Study participants will be recruited by a network of health care professionals. Physicians will collect information from study participants based on questionnaires. This is a one-time survey with no follow-up.

Bayer initiated this study and supports it by an unconditional grant to ZEG. Bayer is not actively involved in the study conduct.

Prolongation of recruitment:

At the beginning of May 2016 the recruitment was finished in 4 of the 5 European countries in which the study is conducted (Austria, Czech Republic, The Netherlands, and Spain). At that point in time, only few patients were enrolled in France because of a delayed recruitment start. Therefore, it was agreed to extend the recruitment phase in France till January 2017. This will ensure that information on the use of Cyproterone Acetate (combined with Ethinyl Estradiol) will be collected from all participating countries.


Study Type : Observational
Estimated Enrollment : 5000 participants
Time Perspective: Cross-Sectional
Official Title: Drug Utilization Study on the Prescribing Indications for Cyproterone Acetate and Ethinyl Estradiol in 5 European Countries
Study Start Date : March 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : May 2017


Group/Cohort
Cyproterone Acetate and Ethinyl Estradiol
Users of Diane 35 (EE/CPA, BAY86-5264)



Primary Outcome Measures :
  1. Drug utilization pattern of Cyproterone Acetate and Ethinyl Estradiol [ Time Frame: within 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women who are prescribed Cyproterone Acetate combined with Ethinyl Estradiol during the study period.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494297


Contacts
Contact: Karl Pauls, MD 00493094510166 kpauls@zeg-berlin.de
Contact: Christine Hagemann, MPH 00493094510143 hagemann@zeg-berlin.de

Locations
Germany
Center of Epidemiology and Health Research Recruiting
Berlin, Germany, 10115
Contact: Karl Pauls, MD    00493094510166    kpauls@zeg-berlin.de   
Contact: Christine Hagemann, MPH    00493094510143    hagemann@zeg-berlin.de   
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Bayer
Investigators
Principal Investigator: Klaas Heinemann, PhD, MD, MSc, MBA Center for Epidemiology and Health Research Berlin

Responsible Party: Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT02494297     History of Changes
Other Study ID Numbers: ZEG2014_04
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Alopecia
Hirsutism
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Virilism
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Cyproterone
Cyproterone Acetate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents
Contraceptive Agents, Male