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

NCT02349399 | Completed

• 2 other identifiers: 17660DI1402
• Study Type: observational
• Target: 26,065
• Locations: 3 countries
• Sites: 3

Brief 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).

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

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

  up to 12 months

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

  up to 12 months

• 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 Outcomes (2)

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

  up to 12 months

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

  up to 12 months

Study Arms (1)

Drug Utilisation / Cohort 1

New users of CPA/EE in 2011/2012 and in 2014

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

Interventions

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

Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg

Drug Utilisation / Cohort 1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who are new users of CPA/EE in 2011/2012 and in 2014

You may qualify if:

• 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.

You may not qualify if:

• \<365 days recorded history in the database prior to index date
• a prescription of CPA/EE in the year prior to index date

Sponsors & Collaborators

• Bayer: lead

Study Sites (3)

Unknown Facility

Many Locations, Italy

Location

Unknown Facility

Many Locations, Netherlands

Location

Unknown Facility

Many Locations, United Kingdom

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Cyproterone; Ethinyl Estradiol; Cyproterone acetate, ethinyl estradiol drug combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Norpregnatrienes; Norpregnanes; Norsteroids; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: January 28, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

IT (1); NL (1); GB (1)