Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000423

EU PAS number

EUPAS1000000423

Study ID

1000000423

Official title and acronym

DARWIN EU® - Suicidality incidence rates in adult male patients and in patients treated with finasteride and dutasteride

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Germany
Netherlands
Spain
United Kingdom

Study description

Finasteride is a specific inhibitor of 5α-reductase, an enzyme that converts testosterone into dihydrotestosterone. It is approved in Europe for treating benign prostatic hyperplasia (BPH) at 5 mg and androgenetic alopecia at 1 mg and 2.275 mg/dl. Dutasteride, another 5α-reductase inhibitor, is also approved in Europe for moderate-to-severe BPH, either alone or in combination with tamsulosin. In some non-EEA countries, dutasteride is also prescribed for androgenetic alopecia.
Signals of mood changes, including depressed mood, depression, and rarely suicidal ideation, have been reported in patients using finasteride. Depression is listed as a side effect of finasteride, along with anxiety and suicidal thoughts, though their frequency is unknown.
These psychiatric effects were not identified during clinical trials but were later explored in post-marketing observational studies. There is insufficient data in the literature regarding the incidence rates of suicide related events in these populations.
The aim of this study is to evaluate the incidence rates of suicide-related events in adult male patients exposed to finasteride or dutasteride medicines for the conditions of androgenetic alopecia and BPH.
Having incidence rate data would be helpful to contextualise and to give some insight into the impact of the indication on suicide-related events. Further understanding of the safety of these medicines regarding their potential psychiatric effects can help inform regulatory decisions and the assessment of the benefit/risk profile of these medicines.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Marzyeh Amini

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_Protocol_P3-C1-019_Finasteride and Suicide_V5.pdf

English (1.28 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable