Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
ConditionPremature Ejaculation
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-55
SponsorVigonvita Life Sciences
About this trial
This trial adopted a multicenter, randomized, double-blind, placebo-controlled design and consisted of two parts: Part Ⅰ and Part Ⅱ.
Eligibility criteria
Qualifiers
Male participants aged 18 to 55 years old (inclusive).
Diagnosed with premature ejaculation (PE) per the definition issued by the International Society for Sexual Medicine (ISSM).
Participants achieved ≥4 coital ejaculations during the run-in period, with intravaginal ejaculatory latency time (IELT) ≤ 2 min in ≥75% of all sexual intercourse attempts.
Participants had a Premature Ejaculation Diagnostic Tool (PEDT) total score ≥ 11.
Disqualifiers
Participants with known hypersensitivity to any components of VV913 capsules or its placebo, or a prior history of hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).
Participants suffering from erectile dysfunction, defined as a total score ≤21 on the International Index of Erectile Function-5 (IIEF-5).
Participants who had genitourinary diseases that may impair sexual function (e.g., prostatitis, phimosis, urinary tract infection, etc.) or underwent genitourinary surgery within 28 days prior to screening and during the baseline period.
Participants or their female partners diagnosed with psychiatric disorders by psychiatrists, such as major depressive disorder, generalized anxiety disorder, bipolar I disorder, bipolar II disorder, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, alcohol use disorder, schizophrenia or other psychiatric disorders.
Trial design
Treatments tested in this trial
- VV913 2mg Capsules
- VV913 5mg Capsules
- VV913 10mg Capsules
- Placebo
Treatment groups
500 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov