Table 2. Basic design of premature ejaculation (PE) intervention trials.

Trial methodology	Interventional trial
	Drug	Psychotherapeutic
Trial population	1. Lifelong PE;	1. Psychogenic acquired PE;
	2. Etiology specific acquired PE	2. Natural variable PE;
		3. PE-like ejaculatory dysfunction (EjD)
Inclusion/exclusion criteria	1. Intravaginal ejaculatory latency time (IELT) ≤1 min;	1. IELT ≤1 min;
	2. International Society of Sexual Medicine (ISSM) PE definition;	2. ISSM PE definition;
	3. PE diagnostic inventory;	3. PE diagnostic inventory;
	4. IIEF EF ≥26 or ≤26 for acquired PE with ED;	4. IIEF EF ≥26 or ≤26 for acquired PE with ED;
	5. See Table 1-Part 1*	5. See Table 1-Part 1*
Trial design	1. Double-blind, parallel-arm placebo-controlled 12-week;	1. Psychotherapy control;
	2. Head-to-head comparator cross-over placebo-controlled 12-week	2. Trial specific
Outcome measures	1. Stopwatch IELT;	1. Stopwatch IELT;
	2. Single item PROs for control, satisfaction, personal/interpersonal distress;	2. Single item patient-reported outcomes (PROs) for control, satisfaction, personal/interpersonal distress;
	3. Multi-domain PE inventory;	3. Multi-domain PE inventory;
	4. Partner reported outcomes (PaROs);	4. Partner reported outcomes (PaROs);
	5. Trial specific PROs;	5. Trial specific PROs;
	6. Adverse events;	6. Discontinuation rate
	7. Discontinuation rate

*, the inclusion/exclusion criteria listed in Table 1.