A Randomized, Double-blind, Placebo-controlled, Two-cohort, Three-way Crossover Clinical Trial to Evaluate the Pharmacodynamic Effect of Different Doses of TPN171H Tablets in Mild to Moderate Male Erectile Dysfunction
Overview
- Phase
- Phase 2
- Intervention
- TPN171H 2.5mg
- Conditions
- Erectile Dysfunction
- Sponsor
- Vigonvita Life Sciences
- Enrollment
- 84
- Locations
- 8
- Primary Endpoint
- Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study is a randomized, double-blind, placebo-controlled, two-cohort, three-cycle crossover (at least a 5-day cleaning period per cycle), and a multicenter clinical trial design.
Detailed Description
This study is a randomized, double-blind, placebo-controlled, two-cohort, three-cycle crossover (at least a 5-day cleaning period per cycle), and a multicenter clinical trial design. The pharmacodynamic effects of different doses of TPN171H tablets on mild to moderate male patients with erectile dysfunction were evaluated by penile plethysmography (RigiScan PlusTM technique) using audiovisual sexual stimulation (AVSS).
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years to 65 years (inclusive)
- •Males with ED at least 6 months, meets the diagnosis of mild and moderate erectile dysfunction，8≤IIEF-5 ≤ 21
- •Patients who are willing to stay away from any other medicines or treatments for ED during this study period
- •Patients (including partners) who are willing to take proper contraceptive during the study and within 3 months after the study completed
- •Patients who have voluntarily decided to participate in this study, and signed the informed consent form
Exclusion Criteria
- •Patients who have a history of hypersensitivity to other PDE5 inhibitors or TPN171H
- •Patients with anatomical malformations of the penis
- •Patients with primary hypoactive sexual desire
- •Patients with ED, which is caused by any other primary sexual disorder
- •Patients with ED ,which is caused by spinal injury or have had a radical prostatectomy or other surgery
- •Patients who have a penile implant
- •Patients who have not responded to PDE5 inhibitors or who have an adverse reaction leading to discontinuation
- •CYP3A4 potent inhibitors, potent inducers, and moderate inducers (except topical drugs) should be used within 28 days before the start of treatment or during the trial period
- •Subjects who are taking nitrate or NO donor drugs, anti-androgens, guanylate cyclase agonists, or other drugs or treatments for the treatment of ED and cannot be discontinued
- •Patients with the following cardiovascular disease:
Arms & Interventions
Sequence 1
N=14 subjects receive 2.5 mg TPN171H and 10 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2 ; 10 mg Placebo and 5 mg Placebo for Period 3.
Intervention: TPN171H 2.5mg
Sequence 1
N=14 subjects receive 2.5 mg TPN171H and 10 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2 ; 10 mg Placebo and 5 mg Placebo for Period 3.
Intervention: TPN171H 5mg
Sequence 1
N=14 subjects receive 2.5 mg TPN171H and 10 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2 ; 10 mg Placebo and 5 mg Placebo for Period 3.
Intervention: Placebo 5mg
Sequence 1
N=14 subjects receive 2.5 mg TPN171H and 10 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2 ; 10 mg Placebo and 5 mg Placebo for Period 3.
Intervention: Placebo 10mg
Sequence 2
N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2 ; 2.5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: TPN171H 2.5mg
Sequence 2
N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2 ; 2.5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: TPN171H 5mg
Sequence 2
N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2 ; 2.5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: Placebo 5mg
Sequence 2
N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2 ; 2.5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: Placebo 10mg
Sequence 3
N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 2.5 mg TPN171H and 10 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: TPN171H 2.5mg
Sequence 3
N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 2.5 mg TPN171H and 10 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: TPN171H 5mg
Sequence 3
N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 2.5 mg TPN171H and 10 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: Placebo 5mg
Sequence 3
N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 2.5 mg TPN171H and 10 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: Placebo 10mg
Sequence 4
N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg TPN171H and 5 mg Placebo for Period 2; 10 mg Placebo and 5 mg Placebo for Period 3.
Intervention: TPN171H 5mg
Sequence 4
N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg TPN171H and 5 mg Placebo for Period 2; 10 mg Placebo and 5 mg Placebo for Period 3.
Intervention: TPN171H 10mg
Sequence 4
N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg TPN171H and 5 mg Placebo for Period 2; 10 mg Placebo and 5 mg Placebo for Period 3.
Intervention: Placebo 5mg
Sequence 4
N=14 subjects receive 5 mg TPN171H and 10 mg Placebo for Period 1; 10 mg TPN171H and 5 mg Placebo for Period 2; 10 mg Placebo and 5 mg Placebo for Period 3.
Intervention: Placebo 10mg
Sequence 5
N=14 subjects receive 10 mg TPN171H and 5 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: TPN171H 5mg
Sequence 5
N=14 subjects receive 10 mg TPN171H and 5 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: TPN171H 10mg
Sequence 5
N=14 subjects receive 10 mg TPN171H and 5 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: Placebo 5mg
Sequence 5
N=14 subjects receive 10 mg TPN171H and 5 mg Placebo for Period 1; 10 mg Placebo and 5 mg Placebo for Period 2; 5 mg TPN171H and 10 mg Placebo for Period 3.
Intervention: Placebo 10mg
Sequence 6
N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2; 10 mg TPN171H and 5 mg Placebo for Period 3.
Intervention: TPN171H 5mg
Sequence 6
N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2; 10 mg TPN171H and 5 mg Placebo for Period 3.
Intervention: TPN171H 10mg
Sequence 6
N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2; 10 mg TPN171H and 5 mg Placebo for Period 3.
Intervention: Placebo 5mg
Sequence 6
N=14 subjects receive 10 mg Placebo and 5 mg Placebo for Period 1; 5 mg TPN171H and 10 mg Placebo for Period 2; 10 mg TPN171H and 5 mg Placebo for Period 3.
Intervention: Placebo 10mg
Outcomes
Primary Outcomes
Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
Time Frame: Baseline and during audiovisual sexual stimulation（60minutes）
Secondary Outcomes
- The starting time of penile erections of greater than or equal to 60% rigidity(Baseline and during audiovisual sexual stimulation（60minutes）)
- Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).(Baseline and during audiovisual sexual stimulation（minutes）)
- Percentage increase in penile enlargement(Baseline and during audiovisual sexual stimulation（60minutes）)
- The incidence of penile erection rigidity grade ≥ grade III.(Baseline and during audiovisual sexual stimulation（60minutes）)