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New treatment option for Premature (Early) Ejaculation
Official title Proof of Concept Study on BP1.4979 Effect on Primary Premature Ejaculation
ClinicalTrials.gov ID: NCT07047404
What this study is testing
What is BP1.4979?
BP1.4979 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for premature (early) ejaculation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, men only
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nîmes, France
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 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nîmes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.