Premature (Early) EjaculationPhase 2NCT07047404
Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation
A Phase 2 study testing BP1.4979 in people with Premature (Early) Ejaculation, run by Bioprojet at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Premature (Early) Ejaculation
- What is being tested?
- BP1.4979
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital of Nîmes
Nîmes, 30029
Stéphane Droupy, MD
About this study
Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of BP1.4979 in Adult Patients With Primary Premature Ejaculation
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.
Read more
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
Read the detailed description
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.
- Conditions
- Premature (Early) Ejaculation
- Being tested
- BP1.4979, Placebo
- Keywords
- premature (early) ejaculation, primary premature ejaculation, Lifelong premature ejaculation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP1.4979Drug
selective dopamine D3 partial agonist
PlaceboDrug
matching placebo of BP1.4979 30mg tablet
| Study group | Role | What they receive |
|---|---|---|
| BP1.4979 | Experimental | 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 Receives: Drug: BP1.4979 |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start15 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature (Early) EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, randomized, double-blind, placebo-controlled, parallel-group, proof of concept study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioprojet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Study principal investigator, Principal investigator, University hospital of Nîmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047404
- Sponsor's protocol ID
- P24-04/BP1.4979
- Status last verified
- Oct 2025
- First submitted
- 24 Jun 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of BP1.4979 in Adult Patients With Primary Premature Ejaculation
- ClinicalTrials.gov ID
- NCT07047404
- Acronym / sponsor ID
- P24-04/BP1.4979
- Conditions
- Premature (Early) Ejaculation
- Keywords
- premature (early) ejaculation, primary premature ejaculation, Lifelong premature ejaculation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BioprojetUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, randomized, double-blind, placebo-controlled, parallel-group, proof of concept study
| Arm | Type | Receives |
|---|---|---|
| BP1.4979 | Experimental | Drug: BP1.4979One 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 |
| Placebo | Placebo comparator | Drug: PlaceboOne 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP1.4979selective dopamine D3 partial agonist | Drug | BP1.4979 |
| Placebomatching placebo of BP1.4979 30mg tablet | Drug | Placebo |
Primary outcome
Intravaginal ejaculatory latence time (IELT)
Time frame: 12 weeks
IELT measured with a stopwatch started by the partner at vaginal intromission and stopped at the start of intravaginal ejaculation at each sexual encounter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Premature (Early) Ejaculation
Recruiting
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
Erectile Dysfunction, Premature (Early) Ejaculation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study principal investigator principal investigator
University hospital of Nîmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BP1.4979 in people with Premature (Early) Ejaculation, run by Bioprojet at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical monitor, MD (+33 1 47 03 66 33, l.feldmann@bioprojet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravaginal ejaculatory latence time (IELT) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.