BP1.4979 treatment for primary (lifelong) premature ejaculation
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
This study will test whether the drug BP1.4979 can increase time to ejaculation and is safe for adult men with lifelong premature ejaculation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Bioprojet Academic / other |
| Locations | 1 site (Nîmes) |
| Trial ID | NCT07047404 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2, randomized, placebo-controlled proof-of-concept trial enrolling adult men with primary (lifelong) premature ejaculation. Participants will take BP1.4979 or placebo as needed before intercourse over a 12-week treatment period and record intravaginal ejaculatory latency time (IELT), control, and adverse events in a diary. The protocol includes four clinic visits and two phone calls across about 17 weeks for safety checks and questionnaires. The drug targets the dopamine pathway and safety and tolerability will be monitored alongside efficacy measures.
Who should consider this trial
Good fit: Adult males aged 18–50 with a diagnosis of primary (lifelong) premature ejaculation, baseline IELT around one minute, and the ability to have timed intercourse and provide informed consent.
Not a fit: Men with acquired, variable, or pseudo-premature ejaculation, significant cardiac or other exclusionary medical conditions, or those unable to attend the clinic in Nîmes are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, BP1.4979 could meaningfully increase time to ejaculation and improve ejaculatory control and quality of life for men with lifelong premature ejaculation.
How similar studies have performed: Most approved treatments for premature ejaculation act on serotonin; targeting the dopamine pathway is relatively novel and has limited prior clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males aged 18 to 50 years old (both inclusive) * Diagnosis of primary (lifelong) PE according to the investigator * Intravaginal Ejaculatory Latency Time (IELT) estimated by the patient around one (1) minute at screening * Confirmation at randomization visit that at least 3 timed sexual intercourses with each IELT below 90 seconds occurred during the baseline period * Patient must be able to provide an informed consent and voluntarily express a willingness to participate in this study, and must sign and date an informed consent prior to any study specific procedure * Capability to participate in all study tests according to the investigator Exclusion Criteria: * Diagnosis of acquired PE, pseudo-PE or natural variable PE * History of clinically significant abnormalities comprising cardiovascular (including especially prolonged QTc (\>450 ms) and high degree (second and third) atrio-ventricular blocks)), hematological, neurological, and endocrine diseases * Current therapy with any treatment which may impact PE from 4 weeks prior to the screening visit * Current therapy with any treatment displaying dopamine D3 receptor agonist properties from 4 weeks prior to the screening visit * Concomitant intake of psychoactive / chem-sex substances
Where this trial is running
Nîmes
- University Hospital of Nîmes — Nîmes, France (Recruiting)
Study contacts
- Principal investigator: Study principal investigator — University hospital of Nîmes
- Study coordinator: Medical monitor, MD
- Email: l.feldmann@bioprojet.com
- Phone: +33 1 47 03 66 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.