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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
BP1.4979
Drugselective dopamine D3 partial agonist
Placebo
Drugmatching placebo of BP1.4979 30mg tablet
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: BP1.4979Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intravaginal ejaculatory latence time (IELT)
IELT measured with a stopwatch started by the partner at vaginal intromission and stopped at the start of intravaginal ejaculation at each sexual encounter
Time frame
12 weeksOther outcomes
1
Ejaculatory control score per sexual encounter
For each sexual encounter, with or without IMP intake, the patient will grade and report in the diary a 4-point ejaculatory control Likert scale, stated as follows "During this sexual intercourse, was your control over ejaculation: 1-Very poor, 2-Poor, 3-Good, 4-Very good or "No opinion"
Time frame
12 weeks2
Ejaculatory control
5-point ejaculatory Likert scale evaluating the overall impact of the IMP during the previous month. The question is worded as follows: "Did you have a lack of ejaculatory control or ability to postpone ejaculation during the last month?", the answers being: 0: Almost all of the time (\>80%), 1: Most of the time (60-80%), 2: About half of the time (40-60%), 3: Less than half of the time (20-40%), 4: Close to never (\<20%)". Higher scores thus indicate a lower frequency of premature ejaculation.
Time frame
At randomization, visit 2 (4 weeks) and end of treatment visit (12 weeks)3
Male Sexual Health Questionnaire
25-item self-administered questionnaire aiming at assessing erection, ejaculation, satisfaction and sexual activity and desire over the previous month
Time frame
At randomization visit, visit 2 (at 4 weeks) and end of treatment visit (at 12 weeks)4
Patient Global Impression Scale - Improvement (PGI-I)
one item adapted to the patient, to assess if there's been an improvement in his clinical status since the IMP intake. The patient will be asked at Visit 2 and EoT (Visit 4) to select the number that best describes how he has felt during the previous month in comparison to the study onset: 0 = Not assessed, 1 = Very much better, 2 = Much better, 3 = A little better, 4 = The same, 5 = A little worse, 6 = Much worse, 7 = Very much worse.
Time frame
Visit 1 (Randomization), Visit 2 (4 weeks) and end of treatment visit (12 weeks) Source ClinicalTrials.gov