Premature EjaculationPhase 2NCT07722780
Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
A Phase 2 study testing VV913 2mg Capsules, VV913 5mg Capsules and VV913 10mg Capsules in people with Premature Ejaculation, run by Vigonvita Life Sciences at 1 site in China.
Trial summary
This trial adopted a multicenter, randomized, double-blind, placebo-controlled design and consisted of two parts: Part Ⅰ and Part Ⅱ. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- VV913 2mg Capsules, VV913 5mg Capsules and VV913 10mg Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Clinical Trial to Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of Premature Ejaculation
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.
- Conditions
- Premature Ejaculation
- Being tested
- VV913 2mg Capsules, VV913 5mg Capsules, VV913 10mg Capsules, Placebo
- Keywords
- Premature Ejaculation, VV913
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VV913 2mg CapsulesDrug
VV913 2mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
VV913 5mg CapsulesDrug
VV913 5mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
VV913 10mg CapsulesDrug
VV913 10mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
PlaceboDrug
VV913 Placebo Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
| Study group | Role | What they receive |
|---|---|---|
| VV913 2mg group | Experimental | Not described Receives: Drug: VV913 2mg Capsules |
| VV913 5mg group | Experimental | Not described Receives: Drug: VV913 5mg Capsules |
| VV913 10mg group | Experimental | Not described Receives: Drug: VV913 10mg Capsules |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Part I: Week 4; Part II: Week 12
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Part II: Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- More trials run by Vigonvita Life SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hui Jiang, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722780
- Sponsor's protocol ID
- VV913-PE-Ⅱ-01
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Clinical Trial to Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of Premature Ejaculation
- ClinicalTrials.gov ID
- NCT07722780
- Acronym / sponsor ID
- VV913-PE-Ⅱ-01
- Conditions
- Premature Ejaculation
- Keywords
- Premature Ejaculation, VV913
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial adopted a multicenter, randomized, double-blind, placebo-controlled design and consisted of two parts: Part Ⅰ and Part Ⅱ.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VV913 2mg CapsulesVV913 2mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse | Drug | VV913 2mg group |
| VV913 5mg CapsulesVV913 5mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse | Drug | VV913 5mg group |
| VV913 10mg CapsulesVV913 10mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse | Drug | VV913 10mg group |
| PlaceboVV913 Placebo Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse | Drug | Placebo group |
Primary outcome
Mean intravaginal ejaculatory latency time (IELT) over the treatment period
Time frame: Part I: Week 4; Part II: Week 12
Assessed was the mean IELT. IELT is measured with a stopwatch during each sexual intercourse throughout treatment.
7 secondary outcomes
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
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
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
Time frame: Part I: Week 4; Part II: Week 4, Week 8, Week 12
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
Time frame: Part II: Week 4, Week 8, Week 12
Changes from baseline in Premature Ejaculation Profile (PEP)
Time frame: Part II: Week 4, Week 8, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui Jiang principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VV913 2mg Capsules, VV913 5mg Capsules and VV913 10mg Capsules in people with Premature Ejaculation, run by Vigonvita Life Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huaqing Duan (18061926005, huaqing.duan@vigonvita.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean intravaginal ejaculatory latency time (IELT) over the treatment period (time frame: Part I: Week 4; Part II: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.