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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
VV913 2mg Capsules
DrugVV913 2mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
VV913 5mg Capsules
DrugVV913 5mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
VV913 10mg Capsules
DrugVV913 10mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
Placebo
DrugVV913 Placebo Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
Treatment groups
500 Participants
are divided into 4 treatment groupsGroup A: VV913 2mg groupExperimental treatment 1 intervention
Group B: VV913 5mg groupExperimental treatment 1 intervention
Group C: VV913 10mg groupExperimental treatment 1 intervention
Group D: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean intravaginal ejaculatory latency time (IELT) over the treatment period
Assessed was the mean IELT. IELT is measured with a stopwatch during each sexual intercourse throughout treatment.
Time frame
Part I: Week 4; Part II: Week 12Secondary outcomes
1
Mean IELT after the first dose, Week 4 and Week 8 of treatment
Assessed was the mean IELT after the first dose, Week 4 and Week 8 of treatment.
Time frame
Part I: first dose; Part II: first dose, Week 4, Week 82
Changes from baseline in mean IELT after the treatment period
Assessed was the mean change from baseline in mean IELT after the treatment period.
Time frame
Part I: first dose, Week 4; Part II: first dose, Week 4, Week 8, Week 123
Proportion of participants with a mean IELT increase of >1 min, >2 min, and >3 min
Assessed were the proportions of participants whose mean IELT increased by more than 1 min, 2 min, and 3 min.
Time frame
Part I: Week 4; Part II: Week 4, Week 8, Week 124
Geometric mean ratio of mean IELT during the treatment period to baseline mean IELT
Assessed was the geometric mean ratio of mean IELT during the treatment period to baseline mean IELT.
Time frame
Part I: Week 4; Part II: Week 4, Week 8, Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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