Drug Utilization Study on Diane-35 (and Generics) in Three European Healthcare Databases

Acne Vulgaris Clinical Trial

Official title:

Drug Utilization Study on Diane®-35 (and Generics) in European Healthcare Databases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349399
• Other study ID #: 17660
• Secondary ID: DI1402
• Status: Completed
• Phase: N/A
• First received: January 23, 2015
• Last updated: April 4, 2017
• Start date: May 1, 2015
• Est. completion date: March 1, 2016

Study information

• Verified date: April 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics, previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26065
• Est. completion date: March 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• The study population will include all female patients registered in the investigated healthcare databases receiving CPA/EE in 2011 or 2012 (first run) or 2014 (second run), without a prescription of CPA/EE in the year prior to index date. Only patients with recorded history in the database of = 365 days prior to index date will be included in the study.

Exclusion Criteria:

• <365 days recorded history in the database prior to index date

• a prescription of CPA/EE in the year prior to index date

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics
Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 µg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne		up to 12 months
Primary	Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutism		up to 12 months
Primary	Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of other Hyperandrogenic Conditions (e.g. androgenic alopecia, seborrhea, polycystic ovary syndrome)		up to 12 months
Secondary	Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne.		up to 12 months
Secondary	Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptives		up to 12 months

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