Premature Ejaculation
Conditions
Keywords
Premature Ejaculation, VV913
Brief summary
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.
Interventions
DRUGVV913 2mg Capsules
VV913 2mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
DRUGVV913 5mg Capsules
VV913 5mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
DRUGVV913 10mg Capsules
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
Sponsors
Vigonvita Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
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 informed consent. 8. Participants must use reliable contraceptive measures from the date of informed consent signature until 3 months after the last study drug administration.
Exclusion criteria
1. 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). 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 (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. 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 ALT and/or AST \> 2 times the upper limit of normal (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 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. 14. Participants who participated in another clinical trial and received investigational 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean intravaginal ejaculatory latency time (IELT) over the treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Assessed was the mean IELT after the first dose, Week 4 and Week 8 of treatment. |
| 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 | Assessed was the mean change from baseline in mean IELT after the treatment period. |
| 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 | Assessed were the proportions of participants whose mean IELT increased by more than 1 min, 2 min, and 3 min. |
| 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 | Assessed was the geometric mean ratio of mean IELT during the treatment period to baseline mean IELT. |
| Change from baseline in Premature Ejaculation Diagnostic Tool (PEDT) score | Part I: Week 4; Part II: Week 4, Week 8, Week 12 | Assessed was the change from baseline in Premature Ejaculation Diagnostic Tool (PEDT) score. |
| Changes from baseline in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction | Part II: Week 4, Week 8, Week 12 | 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. |
| Changes from baseline in Premature Ejaculation Profile (PEP) | Part II: Week 4, Week 8, Week 12 | 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. |
Countries
China
Contacts
CONTACTHuaqing Duan
PRINCIPAL_INVESTIGATORHui Jiang
Peking University First Hospital
Outcome results
None listed