A multicentre, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of BP1.4979 in adult patients with primary premature ejaculation

Primary premature ejaculation

The primary efficacy endpoint is the mean change on the IELT mean post-baseline values (IELTf) collected from the randomization visit to the end of treatment visit compared to the IELT mean of pre-baseline values (IELTb) collected prior to the randomization visit.

Change in the ejaculatory control per sexual encounter measured by a 4-point Likert scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients, Change in the overall ejaculatory control measured by a 5-point Likert scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients, Change in the Male Sexual Health Questionnaire (MSHQ) total score from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients, Change in the Male Sexual Health Questionnaire (MSHQ) sub-score erection scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients, Change in the Male Sexual Health Questionnaire (MSHQ) sub-score ejaculation scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients, Change in the Male Sexual Health Questionnaire (MSHQ) sub-score ejaculation dysfunction bother item from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients, Change in the Male Sexual Health Questionnaire (MSHQ) sub-score ejaculation satisfaction scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients, Change in the Male Sexual Health Questionnaire (MSHQ) sub-score sexual activity and desire scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients, Patient Global Impression Scale - Improvement (PGI-I) at visit 4 only

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