Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation
ConditionPremature (Early) Ejaculation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-50
SponsorBioprojet
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- BP1.4979
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov