Phase 3 Study of Zertane for Premature Ejaculation

Ampio Pharmaceuticals announced results from its Phase 3 study of Zertane for the treatment of premature ejaculation. The randomized, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of Zertane in 604 intent-to-treat patients. The two study efficacy endpoints were statistically significant prolongation of intravaginal ejaculatory latency time (IELT, defined as the time from vaginal penetration to ejaculation in minutes) compared to placebo and statistically significant improvement in the premature ejaculation profile scores (PEP, which is an accepted and validated questionnaire for the evaluation of the impact on patients with premature ejaculation and their partners) compared to placebo.

Zertane had a median increase in IELT at both the lower and higher doses of 2.37 and 2.4 fold over baseline, respectively. Zertane had a mean increase of 4.07 and 4.26 fold over baseline for low and high dose, respectively. The mean change for all four aspects of the PEP (normal distribution) was significantly hihger in both Zertane treatment groups compared to placebo. No serious adverse events were observed.

Zertane is an oral drug and the active ingredient has multiple mechanisms of actions that can delay ejaculation.

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