Takeaway
- A phase 3 clinical trial shows that treating premature ejaculation (PE) with clomipramine (Anafranil) 15 mg on demand is both effective and safe.
Why this matters
- Most studies of clomipramine for the treatment of PE have focused on a daily regimen 25 or 50 mg, but a daily regimen can increase both risk for adverse effects and cost of treatment.
Study design
- Researchers in this multicenter, double-blind trial studied men with PE randomly assigned to receive either placebo or clomipramine 15 mg for 12 weeks (N=159).
- They instructed patients to ingest a tablet 2-6 hours before sexual intercourse, assessing efficacy based on Intravaginal Ejaculation Latency Time (IELT) and Premature Ejaculation Diagnostic Tool (PEDT) scores.
- Funding: CTC Bio.
Key results
- In the intent-to-treat population, IELT increased significantly in the clomipramine 15-mg group compared with the placebo group (mean±SD: 4.4±5.3 vs 2.7±2.0; P<.05>
- PEDT scores varied significantly between groups (−5.2±5.3 vs −1.50±3.5; P<.001>
- Adverse events included mild to moderate nausea (15.7%) or dizziness (4.9%).
Limitations
- Inclusion criteria were not based on the most recent International Society for Sexual Medicine definition of PE.
- The study did not distinguish between lifelong and acquired PE.
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