RecruitingPHASE2INTERVENTIONAL

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

This study is looking into a new drug called BP1.4979 for men who have primary premature ejaculation. This is when ejaculation happens very quickly during sex, right from their very first sexual experience. The main goals are to find out if this drug can help men last longer during sex and to check that it is safe to use. We'll be comparing BP1.4979 to a 'placebo' – a pill that looks the same but contains no active medicine. Participants will take the pill before sex for 12 weeks, keep a diary, and have a few clinic visits and phone calls over about 17 weeks.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Bioprojet

Enrolment target

Start

15 Sep 2025

Estimated completion

01 Dec 2026

Premature (Early) Ejaculation

What is this study about?

This study is focusing on premature ejaculation, which is when a man ejaculates very quickly during sex with a partner. This often happens within about a minute of penetration and can be upsetting for both partners. There are different types, and this study specifically looks at 'primary premature ejaculation,' which means it's been happening since a man's very first sexual experiences and isn't caused by other health issues.

While we don't fully understand why primary premature ejaculation happens, it might be linked to brain chemicals like serotonin and dopamine, or other factors. Current treatments include certain medicines or creams, but they don't always work well for everyone. This leaves many men feeling that there isn't a good solution for them. The study aims to find a new, effective treatment for primary premature ejaculation that could improve men's quality of life.

The new drug being tested is called BP1.4979. It works on a different brain pathway involving dopamine, which might help men better control when they ejaculate. We're testing this drug against a 'placebo,' which is a tablet that looks identical but doesn't contain any medicine. This helps us see if any improvements are truly due to the new drug or just other factors. Participants won't know if they're getting the actual drug or the placebo, and neither will the study doctors; this is called a 'double-blind' study and helps make sure the results are fair.

Key takeaways

The study is testing a new drug (BP1.4979) for primary premature ejaculation.
It aims to see if the drug helps men last longer during sex and if it's safe.
Participants will take the study drug or a dummy pill (placebo) before sex.
The study involves clinic visits, phone calls, and keeping a diary over about 17 weeks.
Neither you nor your doctor will know if you're getting the active drug or placebo.
The goal is to find better treatment options for this condition.

Who may be eligible?

This study is looking for men aged between 18 and 50 years old. To be included, doctors must have diagnosed you with primary (lifelong) premature ejaculation, meaning it's been an issue since your first sexual experiences.

Specifically, you should typically ejaculate around a minute or less after penetration during sex. We'll check this by having you time at least three sexual encounters during a 'baseline' period, where ejaculation happens within 90 seconds. You also need to be able to understand the study, agree to participate, and be able to come to all the required study appointments.

If you have other health conditions like serious heart problems, blood disorders, nerve problems, or hormone issues, you won't be able to join. Also, if you're taking any treatments for premature ejaculation, or certain other medications that affect dopamine, or if you use recreational drugs, you won't be eligible to take part. The study is only for primary premature ejaculation, so if yours started later in life or is linked to other sexual problems, you won't qualify.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged between 18 and 50?
Have you been diagnosed with primary (lifelong) premature ejaculation?
Do you typically ejaculate around a minute (or less) after penetration during sex?
Are you able to attend clinic visits and keep a daily diary?
Do you have any serious heart conditions or other major ongoing health issues?
Are you currently taking any other treatments for premature ejaculation or certain other medications?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be asked to take either the study drug, BP1.4979, or a placebo (dummy pill) as needed before sexual activity for 12 weeks. You'll complete 4 clinic visits for check-ups and questionnaires, and have 2 phone calls with the study team. Over the full study period, which lasts about 17 weeks in total, you'll need to keep a daily diary. In this diary, you'll record when you take the study medicine, how long you last during sex, your feeling of control over ejaculation, any new health issues you notice, and any other medicines you might be taking.

Potential risks and benefits

Taking part in this study could potentially help us find a new and more effective treatment for primary premature ejaculation, which might benefit you and others in the future. However, as with any new medicine, there's a chance of side effects, and the drug might not work for everyone. Because you might receive a placebo, there's also a chance you won't get any active treatment. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Hospital of Nîmes
Verified postcode
Nîmes, France· Recruiting

Common questions

What is 'primary premature ejaculation'?

It's when ejaculation happens very quickly during sex, usually within about a minute of penetration, and has been happening since a man's very first sexual experiences.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study drug but doesn't contain any active medicine. It helps us see if the real drug is truly effective.

Will I know if I'm getting the drug or the placebo?

No, neither you nor the study doctors will know. This is called 'double-blind' and ensures the study results are fair and unbiased.

How long will I take the study medicine?

You will take the study medicine as needed before sex for 12 weeks.

What is the total time commitment for the study?

The study will involve appointments and participation over a period of about 17 weeks.

How to find out more

Medical monitor, MD

l.feldmann@bioprojet.com +33 1 47 03 66 33 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.