Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Name of medicine

DUAVIVE

Medical condition to be studied

Menopausal symptoms
Population studied

Short description of the study population

Study subjects are all patients identified in the respective databases with at least one prescription for Duavive or E+P HRT during the defined study period.
Patients must meet both of the following inclusion criteria to be eligible for this study:
1. All patients identified in the respective databases who have received at least one prescription for Duavive or E+P HRT during the 3 years following the first EU launch of Duavive will be included.
2. Patients need to be enrolled in the data source for at least 12 months prior to their earliest prescription of either Duavive or an (E+P) HRT comparator.

Patients with less than 12 months of database enrolment prior to their index prescription will be excluded.

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

999
Study design details

Main study objective

The overall aim of this drug utilization study (DUS) is to describe the baseline characteristics and utilization patterns of EU patients initiating either Duavive or oestrogen + progestin hormone replacement therapy (E+P HRT).

Data analysis plan

Among Duavive or E+P HRT users, analyses will be descriptive in nature, performed annually for 3 years, and use counts and percentages for categorical variables and means ±with standard deviations for continuous variables. Data from each EU country will be analyzed separately, and may be pooled when feasible, and results will be compared descriptively across countries. Once multiple years of data are available, trends over time will also be reported. The demographics (age, body mass index BMI) and clinical characteristics (co-morbidities, concomitant medications, medical and drug history) of patients identified to have received a Duavive or E+P HRT prescription will be summarized from their 12 month period prior to treatment initiation (pre-index) and compared. The proportions of Duavive patients with possible off-label use will be described.