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

RecruitingPhase 2Ages 18 Years - 50 YearsMaleBioprojet
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In plain words

What the trial is, and whether it could suit you

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, ejaculat

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • BP1.4979
  • Placebo
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Where

1 site
University Hospital of Nîmes
Nîmes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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