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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

26065 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2016-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Risk Minimisation Study for Diane-35 and Its Generics

NCT02410031

Acne Vulgaris

COMPLETED

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

NCT02494297

Hirsutism Androgenetic Alopecia Severe Anemia +2 more

COMPLETED

Comparison of Efficacy and Safety of Norgestimate-ethinyl Estradiol and Cyproterone Acetate-ethinyl Estradiol in the Treatment of Acne Vulgaris

NCT00752635

Acne Vulgaris

COMPLETED PHASE4

Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa

NCT00280657

Acne Vulgaris

COMPLETED PHASE3

Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne

NCT00656981

Acne Vulgaris

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drug Utilisation / Cohort 1

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

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

Intervention Type DRUG

Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.