Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE (NCT07722780) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
China500 participantsStarted 2026-08-31
Plain-language summary
This trial adopted a multicenter, randomized, double-blind, placebo-controlled design and consisted of two parts: Part Ⅰ and Part Ⅱ.
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean intravaginal ejaculatory latency time (IELT) over the treatment period
. 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).