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

NCT07047404 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-06

No results posted yet for this 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

Conditions

  • Premature (Early) Ejaculation

Interventions

DRUG

BP1.4979

selective dopamine D3 partial agonist

DRUG

Placebo

matching placebo of BP1.4979 30mg tablet

Sponsors & Collaborators

Principal Investigators

  • Study principal investigator · University hospital of Nîmes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07047404 on ClinicalTrials.gov