Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE

NCT07722780 | Not Yet Recruiting Phase 2

• 1 other identifier: VV913-PE-Ⅱ-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This trial adopted a multicenter, randomized, double-blind, placebo-controlled design and consisted of two parts: Part Ⅰ and Part Ⅱ.

Conditions

Premature Ejaculation

Keywords

Premature Ejaculation; VV913

Outcome Measures

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.

  Part I: Week 4; Part II: Week 12

Secondary Outcomes (7)

• Mean IELT after the first dose, Week 4 and Week 8 of treatment

  Part I: first dose; Part II: first dose, Week 4, Week 8

• Changes from baseline in mean IELT after the treatment period

  Part I: first dose, Week 4; Part II: first dose, Week 4, Week 8, Week 12

• Proportion of participants with a mean IELT increase of >1 min, >2 min, and >3 min

  Part I: Week 4; Part II: Week 4, Week 8, Week 12

• Geometric mean ratio of mean IELT during the treatment period to baseline mean IELT

  Part I: Week 4; Part II: Week 4, Week 8, Week 12

• Change from baseline in Premature Ejaculation Diagnostic Tool (PEDT) score

  Part I: Week 4; Part II: Week 4, Week 8, Week 12

Study Arms (4)

VV913 2mg group

EXPERIMENTAL

Drug: VV913 2mg Capsules

VV913 5mg group

EXPERIMENTAL

Drug: VV913 5mg Capsules

VV913 10mg group

EXPERIMENTAL

Drug: VV913 10mg Capsules

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

VV913 2mg Capsules DRUG

VV913 2mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse

VV913 2mg group

VV913 5mg Capsules DRUG

VV913 5mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse

VV913 5mg group

Placebo DRUG

VV913 Placebo Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse

Placebo group

VV913 10mg Capsules DRUG

VV913 10mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse

VV913 10mg group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Participants maintained a stable sexual relationship with the same adult female partner for a minimum of 3 months, and intended to sustain this relationship throughout the study period.
• Participants agreed to complete ≥4 coital ejaculations every 28 days during the double-blind treatment period, and were capable of completing all study visits, examinations, assessments and other trial-related procedures as specified in the protocol.
• Participants fully understood the study procedures, volunteered to participate in this trial, and provided written informed consent.
• Participants must use reliable contraceptive measures from the date of informed consent signature until 3 months after the last study drug administration.

You may not qualify if:

• 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.
• Participants' female partners who are pregnant, breastfeeding or planning pregnancy, or suffering from gynecological diseases or receiving relevant treatments that restrict sexual activity.
• Participants with diseases that may affect the absorption of oral medications, such as active enteropathy, partial or complete intestinal obstruction, chronic diarrhea, etc.
• Participants with severe cardiovascular diseases judged by investigators to potentially increase trial risks, including heart failure (NYHA Class II-IV), clinically significant conduction abnormalities (e.g., second- or third-degree atrioventricular block, sick sinus syndrome, etc.), severe or unstable coronary artery disease/ischemic heart disease, severe carotid artery stenosis, left ventricular outflow tract obstruction, etc.
• Participants with active malignant tumors, or a medical history of malignant tumors within 5 years before screening (except completely resected and cured cutaneous squamous cell carcinoma).
• Participants with clinically significant liver or renal function abnormalities, i.e., serum ALT and/or AST \> 2 times the upper limit of normal (ULN), or serum creatinine \> 1.2 times ULN.
• Participants with uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>95 mmHg) or hypotension (systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg).
• Participants who previously discontinued SSRIs or SNRIs due to adverse reactions, or experienced syncope after administration of such drugs.
• Participants who received any anti-premature ejaculation treatment within 28 days before randomization.
• Participants who used monoamine oxidase inhibitors, strong CYP3A4 inhibitors, moderate CYP3A4 inhibitors, strong CYP3A4 inducers or moderate CYP3A4 inducers within 28 days before randomization, or required concomitant use of such agents during the trial.
• Participants who participated in another clinical trial and received investigational medicinal products or medical device treatment within 3 months prior to screening.
• Participants with other conditions deemed ineligible for trial participation by the investigator.

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Hui Jiang

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaqing Duan

CONTACT

18061926005; huaqing.duan@vigonvita.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

CN (1)