A Phase 2 interventional study of BP1.4979 and Placebo in Premature (Early) Ejaculation, sponsored by Bioprojet. Recruiting at 1 site in France. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Bioprojet · Phase 2, Interventional, and Treatment
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:
Participants will:
Premature ejaculation is meant when ejaculation occurs too quickly during sexual activity with a partner, often within one minute of penetration, in 75-100% of sexual encounters and for no other reason. This can be a source of frustration and distress for both partners. There are two main types of PE: lifelong (primary) PE, present from the first sexual experience, and acquired (secondary) PE, which develops later in life and is often associated with other sexual problems (such as reduced libido or erectile dysfunction).
The exact cause of PE remains poorly understood. In the case of primary PE, it may be linked to brain chemicals (such as serotonin and dopamine), nervous system problems or psychological factors.
Current treatments include drugs and non-drug therapies. Medication works by increasing serotonin levels in the brain. They may be authorised, such as dapoxetine (a short-acting antidepressant) and anaesthetic creams (often used to reduce sensitivity, e.g. prilocaine-lidocaine), or prescribed off-label, such as other antidepressants or analgesics (e.g. tramadol). However, these treatments are often of limited efficacy, leaving patients without satisfactory solution.
The objective of this trial is to develop an effective treatment for primary PE specifically and to address an unmet medical need by improving the quality of life of the patients concerned.
The drug under study, called BP1.4979, acts on the dopamine pathway and is being tested to assess whether it can help men suffering from primary PE to better control their ejaculation. The study will compare BP1.4979 with a placebo (a tablet that looks identical but has no active ingredient), taken on demand before sexual intercourse, over a 12-week period.
The study is a double-blind trial compared to a placebo, which means that neither the participants nor the study doctors know who is receiving the study drug or the placebo so as not to influence the results obtained. The treatments will be assigned randomly (by drawing lots), thus forming one group receiving BP1.4979 and another receiving the corresponding placebo.
A visit to the clinical site is planned at the beginning of the selection phase. Participants will be asked to sign an informed consent form prior to any study-related procedure. During the screening phase, they will use a stopwatch to measure the time to ejaculation during sex with a female partner over a period of approximately four weeks and record these times in a diary.
Patients will then return to the clinical site to check whether they are eligible to take part in the study at the 'randomisation visit' and, if so, they will receive the study drug for one month's treatment.
Follow-up visits will take place at week 4 (safety tests and renewal of treatment for two months) and week 12 (final visit). A telephone call will be made at week 8 and week 13 (7 days after stopping treatment) to check or monitor any side effects.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 60 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Bioprojet is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One tablet of BP1.4979 taken per requested need about 2 hours prior to sexual intercourse and at a 12-hour interval minimum over 12 weeks
Drug: BP1.4979
One tablet of matching placebo taken per requested need about 2 hours prior to sexual intercourse and at a 12-hour interval minimum over 12 weeks
Drug: Placebo
selective dopamine D3 partial agonist
matching placebo of BP1.4979 30mg tablet
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 weeks
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 weeks
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)
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)
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)
Safety assessed by Adverse Event (AEs) collection
Safety of BP1.4979 based on AEs reporting during the treatment period.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.
Of 31 phase 2 interventional studies under Premature Birth, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 52. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: BP-14979
Bioprojet