Efficacy and Safety Evaluation of BP1.4979 in Adult Patients with Primary Premature Ejaculation: A Randomized, Double-Blind, Placebo-Controlled Study

Trial ID: 2024-517996-19-00
Protocol: P24-04
Sponsor: Bioprojet Pharma

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Diseases & Conditions

Premature ejaculation

Objectives

The primary objective of this multicentre, randomized, double-blind, placebo-controlled, parallel-group study is to assess the **efficacy** of BP1.4979, administered as needed, compared to placebo, in improving **premature ejaculation** over a 12-week treatment period. This evaluation is clinically relevant as premature ejaculation is a common sexual dysfunction that can significantly impact the quality of life and psychological well-being of affected individuals.

Secondary objectives include:

Assessing the effect of BP1.4979 on ejaculatory control, sexual desire, sexual satisfaction, and erectile function compared to placebo over the same period.
Evaluating and monitoring the safety profile of BP1.4979 in patients with primary premature ejaculation.

These secondary objectives aim to provide a comprehensive understanding of the treatment's impact on various aspects of sexual health and its safety, which are crucial for determining the overall therapeutic value of BP1.4979.

Participants

The clinical trial focuses on evaluating the efficacy of BP1.4979 for the treatment of **primary premature ejaculation** over a 12-week period. The study population consists exclusively of male participants, aged between 18 and 50 years, who have been diagnosed with lifelong premature ejaculation. Participants are required to have an **Intravaginal Ejaculatory Latency Time** (IELT) of approximately one minute at screening, with confirmation of at least three timed sexual intercourses, each with an IELT below 90 seconds, during the baseline period. The trial does not include female subjects or vulnerable populations. The sponsor has not provided information regarding the total number of participants. Participants must be capable of providing informed consent and willing to comply with all study procedures. Lifestyle factors such as diet, physical activity, or habits are not specified as part of the selection criteria.

Plans and Procedures

The clinical trial is designed as a **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 trial will span a total duration of 12 weeks, during which participants will be randomly assigned to receive either the investigational product, BP1.4979, or a placebo. The primary objective is to assess the efficacy of BP1.4979 compared to placebo in improving premature ejaculation, specifically by measuring the mean change in Intravaginal Ejaculatory Latency Time (IELT) from baseline to the end of the treatment period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age, diagnosis of primary premature ejaculation, and baseline IELT. Following successful screening, participants will proceed to the randomization visit (Visit 1), where they will be assigned to their respective treatment groups. Subsequent follow-up visits will occur at regular intervals to monitor safety, efficacy, and adherence to the study protocol. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted.

The expected length of participant involvement is approximately 12 weeks, aligning with the treatment period. Conditions that may lead to early termination from the study include non-compliance with study procedures, withdrawal of consent, or the occurrence of adverse events that, in the investigator's judgment, warrant discontinuation of participation. The primary efficacy endpoint is the mean change in IELT from baseline to the end of treatment, while secondary endpoints include changes in ejaculatory control, overall sexual health, and patient-reported outcomes measured through various scales and questionnaires.

Treatment

The clinical trial involves the evaluation of the experimental medication **BP1.4979**, which is administered in the form of a **tablet**. The active substance in BP1.4979 is **N-[4-[2-[4-(3-cyanophenyl)piperazin-1-yl]ethyl]cyclohexyl]-3-methoxypropanamide**. The medication is intended for **oral use** and is administered as needed, with a maximum daily dose of 60 mg and a total maximum dose of 5040 mg over the course of the 12-week treatment period. The pharmaceutical form is a tablet, and the medication is produced by BIOPROJET. Participant compliance with the dosing schedule will be monitored throughout the study.

The study also includes a **placebo** as a comparator treatment. The placebo is designed to match the experimental medication in appearance and administration route, ensuring the study remains double-blind. The placebo is administered orally, following the same dosing schedule as the experimental medication, to maintain consistency in the treatment protocol. The use of a placebo allows for the assessment of the efficacy and safety of BP1.4979 in comparison to no active treatment.

Efficacy

The efficacy of BP1.4979 in treating **primary premature ejaculation** will be assessed through a multicentre, randomized, double-blind, placebo-controlled, parallel-group study over a 12-week treatment period. The primary efficacy endpoint is the mean change in the Intravaginal Ejaculatory Latency Time (IELT) from baseline to the end of treatment. This will be measured by comparing the mean IELT post-baseline values (IELTf) collected from the randomization visit to the end of treatment visit against the mean IELT pre-baseline values (IELTb) collected prior to the randomization visit.

Secondary efficacy endpoints include several measures of ejaculatory control and sexual health. These will be evaluated using a 4-point Likert scale for ejaculatory control per sexual encounter and a 5-point Likert scale for overall ejaculatory control, both assessed from Visit 1 to Visit 4. Additionally, changes in the Male Sexual Health Questionnaire (MSHQ) total score and sub-scores, including erection scale, ejaculation scale, ejaculation dysfunction bother item, ejaculation satisfaction scale, and sexual activity and desire scale, will be measured from Visit 1 to Visit 4. The Patient Global Impression Scale - Improvement (PGI-I) will be assessed at Visit 4 only.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Males aged 18 to 64 years old (both inclusive)
Diagnosis of primary (life long) PE (premature ejaculation) according to the investigator
Intravaginal Ejaculatory Latency Time (IELT) estimated by the patient around one (1) minute at screening
Confirmation at randomization visit (Visit 1) that at least 3 timed sexual intercourses with each IELT below 90 seconds occurred during the baseline period. IELT values collected during the refractory period (i.e. within 2 hours of a prior ejaculation) are not taken into account for the determination of eligibility.
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

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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
Patients at risk of suicide according to the investigator
Other active clinically significant illness or neoplastic pathology within the last 5 years which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the study or compromise his study participation
Concomitant prolactin-dependent tumour (e.g., pituitary tumour or breast cancer)
Patient who has a laboratory abnormality at screening as follows: • ALT, AST values > 2 x upper limit of normal (ULN) • Serum creatinine value >1.5 x ULN • Absolute neutrophils count <1.0 x10^9 /L • Platelets < 100 x10^9 /L • or who has any other uncontrolled clinically significant laboratory abnormalities that would affect interpretation of the study data or the patient’s participation in the study.
Current therapy with any treatment which may impact PE (including but not limited to dapoxetine, SSRIs, tricyclic antidepressants, tramadol, topical anesthetics, prilocaine/lidocaine and duloxetine) from 4 weeks prior to screening visit
Current therapy with any treatment displaying dopamine D3 receptor agonist properties, including but not limited to: MAO inhibitors antidepressants (iproniazide, moclobemide), antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine), dopamine agonists (metoclopramide, metopimazine, pramipexole, ropinirole, L-Dopa), long-acting benzodiazepines (nitrazepam, bromazepam, diazepam, clobazam, prazepam, clorazepate), antiepileptic drugs (topiramate, zonisamide, lamotrigine) from 4 weeks prior to the screening visit
Concomitant intake of psychoactive / chem-sex substances, including, but not limited to, methamphetamine, gamma-hydroxybutyrate, gamma-butyrolactone or mephedrone from screening visit
Psycho-behavioral therapies and/or PDE5 inhibitors, if already ongoing, must be in place at least 4 weeks prior to screening and not modified (type of reeducation and interval between sessions and/or dosing regimen) till the end of treatment (EoT) visit
History of hypersensitivity to any of the study drug constituents
Patients currently participating in another interventional study and/or having used any investigational therapy within the 30 days prior to screening visit, or a longer and more appropriate time as determined by the investigator (e.g., approximately five half-lives of the previous investigational drug)
Patient not affiliated to a social security scheme