N-[4-[2-[4-(3-CYANOPHENYL)PIPERAZIN-1-YL]ETHYL]CYCLOHEXYL]-3-METHOXYPROPANAMIDE for Primary premature ejaculation | Premature ejaculation

Inclusion criteria

• {"criterion_text":"- 1. Males aged 18 to 50 years old (both inclusive)"}
• {"criterion_text":"- 2.\tDiagnosis of primary (life long) PE (premature ejaculation) according to the investigator"}
• {"criterion_text":"- 3.\tIntravaginal Ejaculatory Latency Time (IELT) estimated by the patient around one (1) minute at screening"}
• {"criterion_text":"- 4.\tConfirmation at randomization visit (Visit 1) that at least 3 timed sexual intercourses with each IELT below 90 seconds occurred during the baseline period"}
• {"criterion_text":"- 5.\tPatient 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"}
• {"criterion_text":"- 6.\tCapability to participate in all study tests according to the investigator"}

Exclusion criteria

• {"criterion_text":"- 1.\tDiagnosis of acquired PE, pseudo-PE or natural variable PE"}
• {"criterion_text":"- 10.\tPsycho-behavioral therapies, if already ongoing, must be in place at least 4 weeks prior to screening and not modified (type of reeducation and interval between sessions) till the end of treatment (EoT) visit"}
• {"criterion_text":"- 11.\tHistory of hypersensitivity to any of the study drug constituents"}
• {"criterion_text":"- 12.\tPatients 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)"}
• {"criterion_text":"- 13.\tPatient not affiliated to a social security scheme"}
• {"criterion_text":"- 2.\tHistory 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"}
• {"criterion_text":"- 3.\tPatients at risk of suicide according to the investigator"}
• {"criterion_text":"- 4.\tOther 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"}
• {"criterion_text":"- 5.\tConcomitant prolactin-dependent tumour (e.g., pituitary tumour or breast cancer)"}
• {"criterion_text":"- 6.\tPatient who has a laboratory abnormality at screening as follows: •\tALT, AST values > 2 x upper limit of normal (ULN) •\tSerum creatinine value >1.5 x ULN •\tAbsolute neutrophils count <1.0 x10^9 /L •\tPlatelets < 100 x10^9 /L •\tor 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."}
• {"criterion_text":"- 7.\tCurrent therapy with any treatment which may impact PE (including but not limited to dapoxetine, SSRIs, tricyclic antidepressants, tramadol, topical anesthetics, prilocaine/lidocaine, PDE5-inhibitors, and duloxetine) from 4 weeks prior to screening visit"}
• {"criterion_text":"- 8.\tCurrent 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"}
• {"criterion_text":"- 9.\tConcomitant intake of psychoactive / chem-sex substances, including, but not limited to, methamphetamine, gamma-hydroxybutyrate, gamma-butyrolactone or mephedrone from screening visit"}

Primary endpoints

• {"endpoint_text":"- The primary efficacy endpoint is the mean change on the IELT mean post-baseline values (IELTf) collected from the randomization visit to the end of treatment visit compared to the IELT mean of pre-baseline values (IELTb) collected prior to the randomization visit.","definition_or_measurement_approach":"Mean change in Intravaginal Ejaculatory Latency Time (IELT): comparison of mean post-baseline IELT (IELTf) collected from randomization to end of treatment versus pre-baseline mean IELT (IELTb) collected prior to randomization."}

Secondary endpoints

• {"endpoint_text":"- Change in the ejaculatory control per sexual encounter measured by a 4-point Likert scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients","definition_or_measurement_approach":"Measured by a 4-point Likert scale comparing Visit 1 to Visit 4."}
• {"endpoint_text":"- Change in the overall ejaculatory control measured by a 5-point Likert scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients","definition_or_measurement_approach":"Measured by a 5-point Likert scale comparing Visit 1 to Visit 4."}
• {"endpoint_text":"- Change in the Male Sexual Health Questionnaire (MSHQ) total score from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients","definition_or_measurement_approach":"Change in MSHQ total score between Visit 1 and Visit 4."}
• {"endpoint_text":"- Change in the Male Sexual Health Questionnaire (MSHQ) sub-score erection scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients","definition_or_measurement_approach":"Change in MSHQ erection sub-score between Visit 1 and Visit 4."}
• {"endpoint_text":"- Change in the Male Sexual Health Questionnaire (MSHQ) sub-score ejaculation scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients","definition_or_measurement_approach":"Change in MSHQ ejaculation sub-score between Visit 1 and Visit 4."}
• {"endpoint_text":"- Change in the Male Sexual Health Questionnaire (MSHQ) sub-score ejaculation dysfunction bother item from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients","definition_or_measurement_approach":"Change in MSHQ ejaculation dysfunction bother item between Visit 1 and Visit 4."}
• {"endpoint_text":"- Change in the Male Sexual Health Questionnaire (MSHQ) sub-score ejaculation satisfaction scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients","definition_or_measurement_approach":"Change in MSHQ ejaculation satisfaction sub-score between Visit 1 and Visit 4."}
• {"endpoint_text":"- Change in the Male Sexual Health Questionnaire (MSHQ) sub-score sexual activity and desire scale from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients","definition_or_measurement_approach":"Change in MSHQ sexual activity and desire sub-score between Visit 1 and Visit 4."}
• {"endpoint_text":"- Patient Global Impression Scale - Improvement (PGI-I) at visit 4 only","definition_or_measurement_approach":"PGI-I measured at Visit 4 only."}

France

Earliest CTIS Part Ii Submission Date

14-04-2025

Latest Decision Or Authorization Date

20-11-2025

Processing Time Days

220

Number Of Sites

16

Number Of Participants

75

Primary sponsor

Full Name

Bioprojet Pharma

Organisation Type

Pharmaceutical company

Country Of Registered Address

France