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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bioprojet Pharma

Participant type

Patients

Age range

18-64 years

Gender

Male

Therapeutic area

Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]

Trial duration

19 Jun 2025 → ongoing

Decision date (initial)

2025-06-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bioprojet Pharma

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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

Secondary objectives 5

1. Assess the effect over a 12-week treatment of BP1.4979 per requested need compared to placebo on the ejaculatory control by the patient
2. Assess the effect over a 12-week treatment of BP1.4979 per requested need compared to placebo on the patient’s sexual desire
3. Assess the effect over a 12-week treatment of BP1.4979 per requested need compared to placebo on the patient’s sexual satisfaction
4. Assess the effect over a 12-week treatment of BP1.4979 per requested need compared to placebo on the patient’s erectile function
5. Evaluate and monitor the safety profile in PE patients over a 12-week treatment with BP1.4979 per requested need compared to placebo

Conditions and MedDRA coding

Primary premature ejaculation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Males aged 18 to 50 years old (both inclusive)
2. 2. Diagnosis of primary (life long) PE (premature ejaculation) according to the investigator
3. 3. Intravaginal Ejaculatory Latency Time (IELT) estimated by the patient around one (1) minute at screening
4. 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
5. 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. 6. Capability to participate in all study tests according to the investigator

Exclusion criteria 13

1. 1. Diagnosis of acquired PE, pseudo-PE or natural variable PE
2. 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. 3. Patients at risk of suicide according to the investigator
4. 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. 5. Concomitant prolactin-dependent tumour (e.g., pituitary tumour or breast cancer)
6. 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. 7. Current 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
8. 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. 9. Concomitant intake of psychoactive / chem-sex substances, including, but not limited to, methamphetamine, gamma-hydroxybutyrate, gamma-butyrolactone or mephedrone from screening visit
10. 10. Psycho-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
11. 11. History of hypersensitivity to any of the study drug constituents
12. 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. 13. Patient not affiliated to a social security scheme

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 9

1. 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
2. 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
3. Change in the Male Sexual Health Questionnaire (MSHQ) total score from Visit 1 to Visit 4 in BP1.4979-treated versus placebo-treated patients
4. 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
5. 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
6. 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
7. 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
8. 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
9. Patient Global Impression Scale - Improvement (PGI-I) at visit 4 only

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bioprojet Pharma

Sponsor organisation

Bioprojet Pharma

Address

9 Rue Rameau

City

Paris

Postcode

75002

Country

France

Scientific contact point

Organisation

Bioprojet Pharma

Contact name

Regulatory Affairs Director

Public contact point

Organisation

Bioprojet Pharma

Contact name

Regulatory Affairs Director

Locations

1 EU/EEA country · 16 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications