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
This trial adopted a multicenter, randomized, double-blind, placebo-controlled design and consisted of two parts: Part Ⅰ and Part Ⅱ.
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.
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
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.
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.
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 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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: VV913 2mg Capsules
Drug: VV913 5mg Capsules
Drug: VV913 10mg Capsules
Drug: Placebo
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
VV913 Placebo Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
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
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
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
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
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
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
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
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
Plan to share: Undecided
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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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Studies of the drug tested here: VV913