The two generic meds, taken only before sex, worked better together than either one alone
STUDY: Kim JH et al, World J Mens Health 2026
STUDY TYPE: Randomized controlled trial
FUNDING: CTCBIO (developer of the combination pill), Soonchunhyang University
Background
Premature ejaculation affects 20% to 30% of men, and few drugs work on demand. Clomipramine delays ejaculation through serotonin reuptake blockade. Sildenafil may help by relaxing the smooth muscle that drives ejaculation.
The Study
- 795 men in Korea (mean age 44) with premature ejaculation and normal erections; 706 completed the trial.
- On-demand clomipramine 15 mg, sildenafil 50 mg, or both combined in one capsule, for 12 weeks.
- Main outcome: stopwatch-timed latency from penetration to ejaculation, starting at under 2 minutes.
Results
Latency rose 4.5 minutes with the combination, compared with 3.2 minutes on clomipramine and 2.7 minutes on sildenafil. The combination outperformed either drug alone by 1.4 to 1.8 minutes, and the difference appeared by week 4.
The extra minute and a half is modest, but it could make a difference for a man finishing within 2 minutes.
Side Effects
Drug-related side effects occurred in 25% on the combination, compared with 16% to 17% on either drug. The most common were nausea (7%), headache (6%), flushing (5%), and dizziness (3%). There were no serious drug reactions.
Limitations
- No placebo group, so placebo response likely inflates the gains.
- Funded by the company developing the pill.
- Short follow-up, Korean men only, and distinct side effects may have revealed treatment assignments.
Practice Implications
- The combination pill isn’t available in the US, but you can prescribe both drugs off-label. Take approximately 4 hours before sex.
- Before prescribing, check for drug interactions that can raise clomipramine. Warning for serotonin syndrome (with SSRIs, tramadol, or other serotonergic drugs), and for nitrates interaction (in heart disease) with sildenafil.
—Chris Aiken, MD
Director, Psych Partners
Editor in Chief, Carlat Psychiatry Report
