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RECRUITING
NCT07047404
PHASE2

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

Sponsor: Bioprojet

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-09-15

Completion Date

2026-12

Last Updated

2025-10-06

Healthy Volunteers

No

Interventions

DRUG

BP1.4979

selective dopamine D3 partial agonist

DRUG

Placebo

matching placebo of BP1.4979 30mg tablet

Locations (1)

University Hospital of Nîmes

Nîmes, France