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

NCT07047404 | Recruiting Phase 2 DMC

• 1 other identifier: P24-04/BP1.4979
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Premature (Early) Ejaculation

Keywords

premature (early) ejaculation; primary premature ejaculation; Lifelong premature ejaculation

Outcome Measures

Primary Outcomes (1)

• Intravaginal ejaculatory latence time (IELT)

  IELT measured with a stopwatch started by the partner at vaginal intromission and stopped at the start of intravaginal ejaculation at each sexual encounter

  12 weeks

Other Outcomes (5)

• Ejaculatory control score per sexual encounter

  12 weeks

• Ejaculatory control

  At randomization, visit 2 (4 weeks) and end of treatment visit (12 weeks)

• Male Sexual Health Questionnaire

  At randomization visit, visit 2 (at 4 weeks) and end of treatment visit (at 12 weeks)

Study Arms (2)

BP1.4979

EXPERIMENTAL

One tablet of BP1.4979 taken per requested need about 2 hours prior to sexual intercourse and at a 12-hour interval minimum over 12 weeks

Drug: BP1.4979

Placebo

PLACEBO COMPARATOR

One tablet of matching placebo taken per requested need about 2 hours prior to sexual intercourse and at a 12-hour interval minimum over 12 weeks

Drug: Placebo

Interventions

BP1.4979 DRUG

selective dopamine D3 partial agonist

BP1.4979

Placebo DRUG

matching placebo of BP1.4979 30mg tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioprojet: lead

Study Sites (1)

University Hospital of Nîmes

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Study principal investigator

  University hospital of Nîmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical monitor, MD

CONTACT

+33 1 47 03 66 33; l.feldmann@bioprojet.com

Clinical Project Manager

CONTACT

+33 1 47 03 66 33; s.renaux@bioprojet.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, randomized, double-blind, placebo-controlled, parallel-group, proof of concept study

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)