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Clinical Trials in France / NCT07047404
Recruiting Phase 2

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

NCT07047404 · tracked via the Priya Life Science France tracker
Sponsor
Bioprojet
Phase
Phase 2
Started
2025-09-15
Last updated
2025-10-06

Condition(s) studied

Premature (Early) Ejaculation

Investigational drug(s) / intervention(s)

BP1.4979 →Placebo

BP1.4979: selective dopamine D3 partial agonist

Placebo: matching placebo of BP1.4979 30mg tablet

Study 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

Eligibility

Sex
MALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Intravaginal ejaculatory latence time (IELT) — 12 weeks
    IELT measured with a stopwatch started by the partner at vaginal intromission and stopped at the start of intravaginal ejaculation at each sexual encounter

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Nîmes Nîmes France Recruiting

More Bioprojet trials in France

Proof of Concept Study on BP1.4979 Effect on Essential Tremor Recruiting
Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07047404 on ClinicalTrials.gov ↗ ← All trials in France