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Not yet recruitingNCT07722780Updated Jul 23, 2026

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

A Phase 2 interventional study of VV913 2mg Capsules and VV913 5mg Capsules in Premature Ejaculation, sponsored by Vigonvita Life Sciences. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Vigonvita Life Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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

Read the detailed description

Part Ⅰ is a 4-week treatment period and Part Ⅱ is a 12-week treatment period, to evaluate the efficacy, safety, and PK/PD relationships of different doses of VV913 capsules in the treatment of premature ejaculation.

02

Conditions studied

  • Premature Ejaculation

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Keywords

  • Premature Ejaculation
  • VV913
03

In context

Premature Ejaculation

106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.

This study's planned enrollment of 500 is above the median of 84 across 89 interventional studies indexed under Premature Ejaculation.

Browse Premature Ejaculation studies →

Lead sponsor

Vigonvita Life Sciences is the lead sponsor of 39 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male participants aged 18 to 55 years old (inclusive).
  2. Diagnosed with premature ejaculation (PE) per the definition issued by the International Society for Sexual Medicine (ISSM).
  3. 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.
  4. Participants had a Premature Ejaculation Diagnostic Tool (PEDT) total score ≥ 11.
  5. 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.
  6. 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.
  7. Participants fully understood the study procedures, volunteered to participate in this trial, and provided written .
  8. Participants must use reliable measures from the date of informed consent signature until 3 months after the last study drug administration.

Exclusion criteria

Exclusion Criteria:

  1. Participants with known 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).
  2. Participants suffering from erectile dysfunction, defined as a total score ≤21 on the International Index of Erectile Function-5 (IIEF-5).
  3. 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.
  4. 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.
  5. Participants' female partners who are pregnant, breastfeeding or planning pregnancy, or suffering from gynecological diseases or receiving relevant treatments that restrict sexual activity.
  6. Participants with diseases that may affect the absorption of oral medications, such as active enteropathy, partial or complete intestinal obstruction, chronic diarrhea, etc.
  7. Participants with severe cardiovascular diseases judged by investigators to potentially increase trial risks, including heart failure ( Class II-IV), 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.
  8. 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).
  9. Participants with clinically significant liver or renal function abnormalities, i.e., serum and/or AST > 2 times the (ULN), or serum creatinine > 1.2 times ULN.
  10. 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).
  11. Participants who previously discontinued SSRIs or SNRIs due to adverse reactions, or experienced syncope after administration of such drugs.
  12. Participants who received any anti-premature ejaculation treatment within 28 days before randomization.
  13. Participants who used monoamine oxidase inhibitors, strong 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.
  14. Participants who participated in another clinical trial and received medicinal products or medical device treatment within 3 months prior to screening.
  15. Participants with other conditions deemed ineligible for trial participation by the investigator.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    VV913 2mg group

    Drug: VV913 2mg Capsules

  • Experimental
    VV913 5mg group

    Drug: VV913 5mg Capsules

  • Experimental
    VV913 10mg group

    Drug: VV913 10mg Capsules

  • Placebo comparator
    Placebo group

    Drug: Placebo

Interventions

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

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

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

  • DrugPlacebo

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

06

What researchers measure

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 12

Secondary 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 8

  2. 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 12

  3. 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 12

  4. 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 12

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

    Assessed was the change from baseline in Premature Ejaculation Diagnostic Tool (PEDT) score.

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

  6. Changes from baseline in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction

    Assessed were the changes from baseline in the IPE domains of ejaculatory control, distress and sexual satisfaction. Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control. Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction. Distress scores range from 2 to 10 with a higher score indicating less distress.

    Time frame: Part II: Week 4, Week 8, Week 12

  7. Changes from baseline in Premature Ejaculation Profile (PEP)

    Assessed were the changes from baseline in scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation.

    Time frame: Part II: Week 4, Week 8, Week 12

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07722780
Responsible party
Sponsor
First posted
Jul 23, 2026
Start date
Aug 31, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 23, 2026

Study contacts

Huaqing Duan
Contact
huaqing.duan@vigonvita.cn
18061926005
Hui Jiang
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: VV913

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