Androgenetic Alopecia, Hirsutism, PCOS, Seborrhea, Severe Anemia
Conditions
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
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.
Interventions
None listed
Sponsors
Bayer
Center for Epidemiology and Health Research, Germany
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol | 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. |
Countries
Germany
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cyproterone Acetate and Ethinyl Estradiol Users of Diane 35 (EE/CPA, BAY86-5264), uncontrolled, single armed drug utilization study | 1,597 |
| Total | 1,597 |
Baseline characteristics
| Characteristic | Cyproterone Acetate and Ethinyl Estradiol |
|---|---|
| Age, Continuous | 26.0 years STANDARD_DEVIATION 7.92 |
| Age, Customized 18-24 years | 647 Participants |
| Age, Customized <18 years | 200 Participants |
| Age, Customized 25-34 years | 533 Participants |
| Age, Customized 35-49 years | 203 Participants |
| Age, Customized >=50 years | 14 Participants |
| Region of Enrollment Austria | 282 participants |
| Region of Enrollment Czech Republic | 563 participants |
| Region of Enrollment France | 108 participants |
| Region of Enrollment Netherlands | 32 participants |
| Region of Enrollment Spain | 612 participants |
| Sex: Female, Male Female | 1597 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cyproterone Acetate and Ethinyl Estradiol | Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol | Moderate or severe acne (without hirsutism) | 594 Participants |
| Cyproterone Acetate and Ethinyl Estradiol | Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol | Acne with hirsutism | 128 Participants |
| Cyproterone Acetate and Ethinyl Estradiol | Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol | Hirsutism without acne | 106 Participants |
| Cyproterone Acetate and Ethinyl Estradiol | Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol | Other androgenic diseases and contraception | 769 Participants |