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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат VV913 2mg Capsules
  VV913 2mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
• Препарат VV913 5mg Capsules
  VV913 5mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
• Препарат VV913 10mg Capsules
  VV913 10mg Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
• Препарат Placebo
  VV913 Placebo Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse

Первичные конечные точки

• Mean intravaginal ejaculatory latency time (IELT) over the treatment period [Срок оценки: Part I: Week 4; Part II: Week 12]

Вторичные конечные точки (7)

• Mean IELT after the first dose, Week 4 and Week 8 of treatment [Срок оценки: Part I: first dose; Part II: first dose, Week 4, Week 8]
• Changes from baseline in mean IELT after the treatment period [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Part I: Week 4; Part II: Week 4, Week 8, Week 12]
• Change from baseline in Premature Ejaculation Diagnostic Tool (PEDT) score [Срок оценки: 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 [Срок оценки: Part II: Week 4, Week 8, Week 12]
• Changes from baseline in Premature Ejaculation Profile (PEP) [Срок оценки: Part II: Week 4, Week 8, Week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Идентификаторы

NCT: NCT07722780 · VV913-PE-Ⅱ-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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