Actively Recruiting
Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation
Led by Bioprojet · Updated on 2025-10-06
60
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 to 50 years old
- Diagnosed with primary (lifelong) premature ejaculation
- Estimated ejaculation time around one minute at screening
- At least 3 timed sexual intercourses with ejaculation time below 90 seconds during baseline
- Able and willing to provide informed consent and participate in all study tests
You will not qualify if you...
- Diagnosis of acquired, pseudo, or natural variable premature ejaculation
- History of significant cardiovascular, hematological, neurological, or endocrine diseases
- Prolonged QTc over 450 ms or high degree (second or third) atrio-ventricular blocks
- Current treatment affecting premature ejaculation within 4 weeks before screening
- Current treatment with dopamine D3 receptor agonists within 4 weeks before screening
- Use of psychoactive or chem-sex substances during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital of Nîmes
Nîmes, France, 30029
Actively Recruiting
Research Team
M
Medical monitor, MD
CONTACT
C
Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here