Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation

The goal of this clinical trial is to learn if drug BP1.4979 works to treat primary premature ejaculation in adults. It will also learn about the safety of drug BP1.4979. The main questions it aims to answer are: * Does drug BP1.4979 increase the time to ejaculation during sexual intercourse? * Do participants have a good safety and tolerability of drug BP1.4979? Researchers will compare drug BP1.4979 to a placebo (a look-alike substance that contains no drug) to see if drug BP1.4979 works to treat primary premature ejaculation. Participants will: * Take drug primary premature ejaculation or a placebo per requested need prior to sexual intercourses for 12 weeks * Visit the clinic 4 times for checkups and questionnaires completion and have 2 phone calls with the study team over a period of about 17 weeks * Keep a diary of the intakes of the experimental drug, ejaculation time, ejaculation control, any unusual events concerning their health and any other medication taken

NCT Number	NCT07047404
Lead Sponsor	Bioprojet
Conditions	Premature (Early) Ejaculation
Enrollment	60 participants
Start Date	2025-09-15
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-10-06