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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
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
Peking University First Hospital
Beijing, Beijing Municipality, China
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
VV913 Placebo Capsules, taken orally on demand, 0.5-4 hours prior to sexual intercourse
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