HirsutismNCT02494297
DUS on the Prescribing Indications for CPA/EE in 5 European Countries
An observational study of Hirsutism and Androgenetic Alopecia, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hirsutism, Androgenetic Alopecia, Severe Anemia
- How many people
- 1,597 participants
- Where
- 1 siteGermany
- Study dates
- 6 Mar 2015to 31 Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women who are prescribed Cyproterone Acetate combined with Ethinyl Estradiol during the study period
Who may be able to join
- 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
Who cannot join
- Women who are not willing to sign the informed consent
- Women with a language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Utilization Study on the Prescribing Indications for Cyproterone Acetate and Ethinyl Estradiol in 5 European Countries
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
Read the 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 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.
- Conditions
- Hirsutism, Androgenetic Alopecia, Severe Anemia, Seborrhea, PCOS
- Medical subject headings
- Hirsutism, Alopecia, Anemia, Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cyproterone Acetate and Ethinyl Estradiol | Users of Diane 35 (EE/CPA, BAY86-5264) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study start6 Mar 2015
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HirsutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Klaas Heinemann, PhD, MD, MSc, MBA, Principal investigator, Center for Epidemiology and Health Research Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494297
- Sponsor's protocol ID
- ZEG2014_04
- Status last verified
- Aug 2021
- First submitted
- 8 Jul 2015
- Last updated
- 27 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilization Study on the Prescribing Indications for Cyproterone Acetate and Ethinyl Estradiol in 5 European Countries
- ClinicalTrials.gov ID
- NCT02494297
- Acronym / sponsor ID
- ZEG2014_04
- Conditions
- Hirsutism, Androgenetic Alopecia, Severe Anemia, Seborrhea, PCOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,597 participants (actual)
- Lead sponsor
- Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 6 Mar 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Posted 27 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyproterone Acetate and Ethinyl Estradiol | – | –Users of Diane 35 (EE/CPA, BAY86-5264) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who are prescribed Cyproterone Acetate combined with Ethinyl Estradiol during the study period
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Women who are not willing to sign the informed consent
- Women with a language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol
Time frame: within 18 months
Information was obtained from doctors prescribing CPA/EE. Categories in the Outcom Measure Data Table below are based on current disease status.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Study Synopsis from Bayer AGLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hirsutism
Recruiting
Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
PCOS (Polycystic Ovary Syndrome), Obese Adolescents
Recruiting
Effect of Magnesium and Levocarnitine on Metabolic and Clinical Outcomes in Women With Polycystic Ovarian Syndrome (PCOS)
Polycystic Ovary Syndrome (PCOS)
RecruitingPhase 4
Comparison of a Face Cream Plus a Laser Procedure and Face Cream Alone in Treatment of Excessive Face Hairs in Female
Hirsuitism
RecruitingObservational study
Treatment of Hypertrichosis With Intense Pulsed Light
Hypertrichosis, Hirsutism - Hypertrichosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaas Heinemann, PhD, MD, MSc, MBA principal investigator
Center for Epidemiology and Health Research Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hirsutism and Androgenetic Alopecia, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol (time frame: within 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.