Pryor 2006.

Study characteristics
Methods	Study design: blinded, randomized controlled, parallel‐group trial Setting/country: multi‐institution, Dapoxetine Study Group in DE&MN, USA Dates study conducted: June 2003 to June 2004
Participants	Inclusion criteria: Men with PE who were more severely affected with the condition than the general population of men self‐identifying with symptoms of PE in surveys Age > 18 years and in a stable sexual relationship with a female partner for ≥ 6 months Men had to meet the diagnostic criteria for PE as specified in the DSM‐IV‐TR: onset of orgasm Participant and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol Participant's partner must have had a negative urine pregnancy test at time of screening Exclusion criteria: Severity of PE was further assessed by patients' responses to the statement: "I consider the severity of my rapid ejaculation problem to be (none, mild, moderate, severe)." Men who regarded themselves as having no or mild PE ED or other forms of sexual dysfunction Concomitant use of SSRIs or tricyclic antidepressants History of major psychiatric disorder Use of other forms of therapy for PE (pharmacologic or behavioral) Men whose partners had problems with self‐reported female sexual dysfunction No known allergy or hypersensitivity to dapoxetine or other SSRIs No partners with decreased interest in or painful intercourse or other forms of sexual dysfunction Total number of participants randomized: NR Total length of study: 12 weeks Group 1 (dapoxetine 30 mg): Number of participants randomized: 870 Age (mean): 40.3 (SD 9.10) years Baseline IELT (mean): 0.90 (SD 0.47) minutes Number of participants with primary PE: 563 Number of participants with secondary PE: 227 Group 2 (dapoxetine 60 mg): Number of participants randomized: 874 Age (mean): 40.9 (SD 9.09) years Baseline IELT (mean): 0.92 (SD 0.50) minutes Number of participants with primary PE: 571 Number of participants with secondary PE: 234 Group 3 (placebo): Number of participants randomized: 870 Age (mean): 40.3 (SD 9.55) years Baseline IELT (mean): 0.91 (SD 0.48) minutes Number of participants with primary PE: 560 Number of participants with secondary PE: 248
Interventions	Group 1: dapoxetine 30 mg on‐demand 1–3 hours before anticipated sexual activity Group 2: dapoxetine 60 mg on‐demand 1–3 hours before anticipated sexual activity Group 3: placebo on‐demand 1–3 hours before anticipated sexual activity
Outcomes	Primary outcomes: IELT How measured: using a stopwatch Time points measured: 0, 4, 8, 12 weeks Secondary outcomes: Participant satisfaction with sexual intercourse How measured: participant‐reported scale (0–5) Time points measured: 0, 4, 8, 12 weeks Other outcomes: Participant perception of control over ejaculation How measured: participant‐reported scale (0–5) Time points measured: 0, 4, 8, 12 weeks Other outcomes: Partner satisfaction with sexual intercourse How measured: participant‐reported scale (0–5) Time points measured: 0, 4, 8, 12 weeks Other outcomes: Participant rating of severity of PE How measured: participant‐reported scale (0–5) Time points measured: 0, 4, 8, 12 weeks Other outcomes: Adverse events How measured: participant reported Time points measured: anytime
Funding sources	NR
Declarations of interest	SE Althof, RC Rosen, WJG Hellstrom and R Shabsigh have served as consultants for Johnson & Johnson. R Shabsigh has also received grant/research support from Johnson & Johnson. M Miloslavsky and S Kell are employees of ALZA Corporation. JL Pryor and C Steidle have served on advisory boards for ALZA Corporation.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomly assigned within each stratum 1:1:1 by a computerised interactive voice recognition system."
Allocation concealment (selection bias)	Low risk	Randomly assigned within each stratum 1:1:1 by a computerized interactive voice recognition system.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Probably double blind. Quote: "tablets in all groups were identical in appearance;" "Investigator assessed adverse event severity."
Blinding of outcome assessment (detection bias) Participant‐reported outcomes	Low risk	Tablets in all groups were identical in appearance.
Blinding of outcome assessment (detection bias) Investigator‐assessed outcomes	Low risk	Investigator assessed adverse event severity.
Blinding of outcome assessment (detection bias) IELT	Low risk	Objective measurement that is unlikely to be influenced by blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "All analyses were done on an intention‐to‐treat basis." All participants were included in the analysis.
Selective reporting (reporting bias)	Low risk	As reported in protocol in ClinicalTrials.gov.
Other bias	Low risk	No clear source identified.