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Study on the Effectiveness of BP1.4979 for Adult Men with Premature Ejaculation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as primary premature ejaculation, which is a common sexual issue where ejaculation happens sooner than desired during sexual activity. The study will evaluate a treatment using a medication with the code name BP1.4979. This medication is taken in the form of a tablet and is being compared to a placebo to see how effective it is in improving the condition.

The purpose of the study is to assess the effectiveness and safety of BP1.4979 over a 12-week period. Participants will be randomly assigned to receive either the medication or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure the results are unbiased. Throughout the study, participants will be asked to report on their experiences and any changes they notice in their condition.

The study will involve several visits where participants will provide feedback on their condition, including their control over ejaculation and overall sexual health. This feedback will be collected using various questionnaires and scales to measure changes over time. The goal is to determine if BP1.4979 can significantly improve the symptoms of primary premature ejaculation compared to the placebo.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization visit
At the start of the trial, you will attend a randomization visit. During this visit, it will be confirmed that you have had at least three timed sexual intercourses with each lasting less than 90 seconds during the baseline period.
You will be randomly assigned to receive either the study medication, BP1.4979, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.
Step 2
Medication administration
You will take the assigned medication in the form of a tablet by oral use. The medication is to be taken as needed over a 12-week treatment period to assess its effectiveness in improving premature ejaculation.
Step 3
Follow-up visits
Throughout the trial, you will attend several follow-up visits. These visits are designed to monitor your progress and gather data on the medication's effectiveness.
During these visits, changes in your ejaculatory control will be measured using a 4-point Likert scale and a 5-point Likert scale. Additionally, you will complete the Male Sexual Health Questionnaire (MSHQ) to assess various aspects of your sexual health.
Step 4
End of treatment visit
At the end of the 12-week period, you will have a final visit to evaluate the overall effects of the treatment.
The primary measure of success will be the change in your Intravaginal Ejaculatory Latency Time (IELT) from the start to the end of the trial. This will help determine the effectiveness of the medication compared to the placebo.

Who can join the trial?

6 criteria

Males aged 18 to 50 years old can participate.
Must have a diagnosis of primary (life-long) premature ejaculation as determined by the study doctor.
Must have an Intravaginal Ejaculatory Latency Time (IELT) of about one minute. This means the time it takes to ejaculate during intercourse is around one minute.
At the start of the study, must confirm that during the initial period, at least three sexual intercourses had an IELT of less than 90 seconds.
Must be able to provide informed consent, which means understanding the study and agreeing to participate by signing a consent form.
Must be able to participate in all study tests as determined by the study doctor.

Who cannot join the trial?

3 criteria

Patients who do not have primary premature ejaculation cannot participate. This means the study is only for those who have this specific condition.
Only male patients can participate. Female patients are not eligible for this study.
Patients who are part of a vulnerable population cannot participate. This generally refers to groups who may need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Et Universitaire De Limoges
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Limoges, France
Centre Hospitalier Lyon Sud
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Pierre Benite, France
Centre Hospitalier Universitaire Amiens Picardie
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Amiens, France

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Investigated drugs

BP1.4979 is a medication being tested in this clinical trial to see if it can help men who experience premature ejaculation. Premature ejaculation is when a man ejaculates sooner during sexual activity than he or his partner would like. This medication is being studied to find out if it can help men last longer before ejaculating, improving their sexual experience. The trial is designed to compare the effects of BP1.4979 to a placebo, which is a substance with no active medication, to see if BP1.4979 is effective in treating this condition.

N-[4-[2-[4-(3-Cyanophenyl)Piperazin-1-Yl]Ethyl]Cyclohexyl]-3-Methoxypropanamide

What is already known about the treatment

BP1.4979 – BP1.4979 is administered as needed to adult patients and is currently being studied in clinical trials for its effectiveness in treating primary premature ejaculation. This medication is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for BP1.4979 is to help improve the condition of premature ejaculation, which is a common sexual dysfunction in men. At the molecular level, the mechanism of action for BP1.4979 is not fully detailed in the available data, but it is being evaluated for its potential to delay ejaculation. It falls under the pharmacological classification of treatments for sexual dysfunction.

Investigated diseases

Primary Premature Ejaculation – Primary premature ejaculation is a sexual dysfunction characterized by ejaculation that occurs sooner than desired, either before or shortly after penetration, causing distress to one or both partners. It is considered a lifelong condition, typically present from the first sexual experiences. The condition is believed to involve a complex interaction of psychological and biological factors, including neurotransmitter imbalances and heightened penile sensitivity. Men with this condition often experience a lack of control over ejaculation, leading to reduced sexual satisfaction. The progression of primary premature ejaculation can vary, with some individuals experiencing consistent symptoms over time, while others may notice changes in severity. The condition can impact emotional well-being and interpersonal relationships, contributing to anxiety and avoidance of sexual intimacy.