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Completed

NCT Number: NCT02349399

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

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).

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–64 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics

Drug

Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg

Primary outcomes

  1. Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne

    Time frame: up to 12 months

  2. Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutism

    Time frame: up to 12 months

  3. 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)

    Time frame: up to 12 months

Secondary outcomes

  1. Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne.

    Time frame: up to 12 months

  2. Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptives

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2015
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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