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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
EU CTIS ID: 2024-517996-19-00
What this study is testing
The primary objective of the study is to assess over a 12-week treatment period the efficacy of BP1.4979 per requested need compared to placebo on the improvement of premature ejaculation
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Males aged 18 to 64 years old (both inclusive)
- 2. Diagnosis of primary (life long) PE (premature ejaculation) according to the investigator
- 3. Intravaginal Ejaculatory Latency Time (IELT) estimated by the patient around one (1) minute at screening
- 4. 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.
- 5. 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
- 6. Capability to participate in all study tests according to the investigator
You likely can't join if
- 1. Diagnosis of acquired PE, pseudo-PE or natural variable PE
- 10. 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
- 11. History of hypersensitivity to any of the study drug constituents
- 12. 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)
- 13. Patient not affiliated to a social security scheme
- 2. 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
See the full eligibility criteria
Who can join
- 1. Males aged 18 to 64 years old (both inclusive)
- 2. Diagnosis of primary (life long) PE (premature ejaculation) according to the investigator
- 3. Intravaginal Ejaculatory Latency Time (IELT) estimated by the patient around one (1) minute at screening
- 4. 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.
- 5. 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
- 6. Capability to participate in all study tests according to the investigator
What rules you out
- 1. Diagnosis of acquired PE, pseudo-PE or natural variable PE
- 10. 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
- 11. History of hypersensitivity to any of the study drug constituents
- 12. 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)
- 13. Patient not affiliated to a social security scheme
- 2. 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
- 3. Patients at risk of suicide according to the investigator
- 4. 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
- 5. Concomitant prolactin-dependent tumour (e.g., pituitary tumour or breast cancer)
- 6. 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.
- 7. 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
- 8. 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
- 9. Concomitant intake of psychoactive / chem-sex substances, including, but not limited to, methamphetamine, gamma-hydroxybutyrate, gamma-butyrolactone or mephedrone from screening visit
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.