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Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation
Sponsor: Bioprojet
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
Conditions
Interventions
BP1.4979
selective dopamine D3 partial agonist
Placebo
matching placebo of BP1.4979 30mg tablet
Locations (1)
University Hospital of Nîmes
Nîmes, France