An observational study in Hirsutism, Androgenetic Alopecia and Severe Anemia, sponsored by Center for Epidemiology and Health Research, Germany. Completed at 1 site in Germany. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-27.
Sponsored by Center for Epidemiology and Health Research, Germany · Observational
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:
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 was a multi-national, cross sectional, prospective, non-interventional, drug utilization study conducted in 5 countries. Study participants were recruited by a network of health care professionals. Physicians collected information from study participants based on questionnaires. This was a one-time survey with no follow-up.
Bayer initiated this study and supported it by an unconditional grant to ZEG. Bayer was 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 was 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 until 31st October 2016, in order to ensure that information on the use of Cyproterone Acetate (combined with Ethinyl Estradiol) would be collected from all participating countries.
41 studies on the registry are indexed under Hirsutism; 8 are open to participants now.
This study's enrollment of 1,597 is above the median of 206 across 14 observational studies indexed under Hirsutism.
Browse Hirsutism studies →Center for Epidemiology and Health Research, Germany is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women who are prescribed Cyproterone Acetate combined with Ethinyl Estradiol during the study period
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Users of Diane 35 (EE/CPA, BAY86-5264)
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.
Time frame: within 18 months
Recruitment from March-2015 to 11-May-2016 in Austria, Czech Republic, The Netherlands and Spain; recruitment in France from January-2016 to 31-October-2016, due to late start. Recruitment was conducted by gynecologists, dermatologists and general practitioners.
| Milestone | Cyproterone Acetate and Ethinyl Estradiol |
|---|---|
| Started | 1597 |
| Completed | 1597 |
| Not completed | 0 |
Information was obtained from doctors prescribing CPA/EE. Categories in the Outcom Measure Data Table below are based on current disease status.
| Participants | Cyproterone Acetate and Ethinyl Estradiol |
|---|---|
| Moderate or severe acne (without hirsutism) | 594 |
| Acne with hirsutism | 128 |
| Hirsutism without acne | 106 |
| Other androgenic diseases and contraception | 769 |
Collected over Adverse events were not monitored in this study, which was a non-interventional observational cross sectional study on drug utilization patterns that exclusively obtained information at the time point of prescription. There were no questions that could generate adverse events (AEs) and no follow-up questionnaires.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cyproterone Acetate and Ethinyl Estradiol | — | — | — |
| Age, Continuous(years) | Cyproterone Acetate and Ethinyl Estradiol |
|---|---|
| Mean | 26.0 ± 7.92 |
| Age, Customized(Participants) | Cyproterone Acetate and Ethinyl Estradiol |
|---|---|
| <18 years | 200 |
| 18-24 years | 647 |
| 25-34 years | 533 |
| 35-49 years | 203 |
| >=50 years | 14 |
| Sex: Female, Male(Participants) | Cyproterone Acetate and Ethinyl Estradiol |
|---|---|
| Female | 1597 |
| Male | 0 |
| Region of Enrollment(participants) | Cyproterone Acetate and Ethinyl Estradiol |
|---|---|
| Austria | 282 |
| Czech Republic | 563 |
| France | 108 |
| Netherlands | 32 |
| Spain | 612 |
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Center for Epidemiology and Health Research, Germany