DUS on the Prescribing Indications for CPA/EE in 5 European Countries (NCT02494297) | Clinical Trial Compass
CompletedNot Applicable
DUS on the Prescribing Indications for CPA/EE in 5 European Countries
Germany1,597 participantsStarted 2015-03-06
Plain-language 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
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol
Timeframe: within 18 months
Trial details
NCT IDNCT02494297
SponsorCenter for Epidemiology and Health Research, Germany