Status: Ongoing First registered on: 03/04/2020
Last updated on: 07/04/2020
1. Study identification
EU PAS Register NumberEUPAS34531
Official titleSuicide and suicidality after exposure to finasteride
Study title acronymSuicidality with finasteride
Study typeObservational study
Brief description of the studyFinasteride – indicated for benign prostatic hyperplasia (BPH) and male pattern hair loss (MPHL) - is known to cause psychiatric side effects. There are ongoing signals of persistence of psychiatric events after discontinuation of finasteride and of suicide/self-injury which remain under close monitoring. The principal objectives of this study are: (i) to assess the extent to which patients prescribed finasteride 5mg (BPH indication) are at increased risk of recorded suicide and suicide-related outcomes compared with patient prescribed alternative treatments for BPH; (ii) to assess if any association between finasteride 5mg exposure and recorded suicidality persists after cessation of therapy; and (iii) to describe the pattern of recorded events in patients prescribed finasteride 1mg (MPHL indication). This will be a cohort study with cohorts defined based on patients’ exposure to the medicines under investigation. The population eligible for the study will consist of male patients (finasteride is not indicated for use in females) registered with an IMRD-UK registered GP-practice for a duration of one-year or more. To avoid potential confounding relating to differing baseline risks a covariate adjusted analysis will be used. This will require the use of a minimum one-year lookback period prior to the start of follow-up to establish any baseline comorbidities. The primary analysis will be a new-user “inception” cohort of patients established through the one-year screening period to define incident use. Patients will be followed from the date of first prescription until an event or censored. The primary (composite) analysis will follow-up until first event and the secondary (component part / alternative composite) analysis will follow-up until first event of each type. Patients will be censored at the end of follow-up or when they switch to alternative therapy for BPH.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameEuropean Medicines Agency
Centre locationThe Netherlands
Details of (Primary) lead investigator
Title Dr
Last name Robert
First name Flynn
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/02/202001/02/2020
Start date of data collection01/02/202001/02/2020
Start date of data analysis01/04/202001/04/2020
Date of interim report, if expected
Date of final study report30/06/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherInternally EMA funded study100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Robert
First name Flynn
Address line 1Domenico Scarlattilaan 6
Address line 2 
Address line 3 
CityAmsterdam 
Postcode1083 HS 
CountryNetherlands
Phone number (incl. country code)31887818439 
Alternative phone number 
Fax number (incl. country code) 
Email address robert.flynn@ema.europa.eu
Public Enquiries
Title Dr 
Last name Robert 
First name Flynn 
Address line 1Domenico Scarlattilaan 6 
Address line 2 
Address line 3 
CityAmsterdam 
Postcode1083 HS 
CountryNetherlands 
Phone number (incl. country code)31887818439 
Alternative phone number 
Fax number (incl. country code) 
Email address robert.flynn@ema.europa.eu 
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