Trial Outcomes & Findings for DUS on the Prescribing Indications for CPA/EE in 5 European Countries (NCT NCT02494297)

Last Updated: 2021-08-27

Results Overview

Information was obtained from doctors prescribing CPA/EE. Categories in the Outcom Measure Data Table below are based on current disease status.

Recruitment status

COMPLETED

Target enrollment

1597 participants

Primary outcome timeframe

within 18 months

Results posted on

2021-08-27

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Cyproterone Acetate and Ethinyl Estradiol Users of Diane 35 (EE/CPA, BAY86-5264), uncontrolled, single armed drug utilization study
Overall Study STARTED	1597
Overall Study COMPLETED	1597
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DUS on the Prescribing Indications for CPA/EE in 5 European Countries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyproterone Acetate and Ethinyl Estradiol n=1597 Participants Users of Diane 35 (EE/CPA, BAY86-5264), uncontrolled, single armed drug utilization study
Age, Continuous	26.0 years STANDARD_DEVIATION 7.92 • n=99 Participants
Age, Customized <18 years	200 Participants n=99 Participants
Age, Customized 18-24 years	647 Participants n=99 Participants
Age, Customized 25-34 years	533 Participants n=99 Participants
Age, Customized 35-49 years	203 Participants n=99 Participants
Age, Customized >=50 years	14 Participants n=99 Participants
Sex: Female, Male Female	1597 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment Austria	282 participants n=99 Participants
Region of Enrollment Czech Republic	563 participants n=99 Participants
Region of Enrollment France	108 participants n=99 Participants
Region of Enrollment Netherlands	32 participants n=99 Participants
Region of Enrollment Spain	612 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cyproterone Acetate and Ethinyl Estradiol n=1597 Participants Users of Diane 35 (EE/CPA, BAY86-5264), uncontrolled, single armed drug utilization study
Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol Moderate or severe acne (without hirsutism)	594 Participants
Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol Acne with hirsutism	128 Participants
Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol Hirsutism without acne	106 Participants
Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol Other androgenic diseases and contraception	769 Participants

Adverse Events

Cyproterone Acetate and Ethinyl Estradiol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Klaas Heinemann

Center for Epidemiology and Health Research, Germany

Phone: 0049 (0) 30 945 101 20

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place