BP1.4979 treatment for primary (lifelong) premature ejaculation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pelvic floor therapy for erectile dysfunction and premature ejaculation

  This study is testing if pelvic floor therapy can help men with erectile dysfunction and premature ejaculation feel better after 12 weeks of treatment.

  Recruiting Boston Medical Group · Bogotá, Cundinamarca · NCT06425211

• BP1.4979 to reduce essential tremor.

  See if BP1.4979, taken twice daily for four weeks, reduces tremors and is safe in adults with essential tremor.

  Recruiting at 2 sites Phase 2 Bioprojet · Amiens and 13 other locations · NCT07074002

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.