Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.
NCT05188989 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 765
Last updated 2023-03-07
Summary
This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of TPN171H in men with erectile dysfunction.
Conditions
Interventions
- DRUG
-
TPN171H 2.5mg group
TPN171H 2.5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
- DRUG
-
TPN171H 5mg group
TPN171H 5mg taken orally on demand 0.5-4 hour prior to sexual intercourse
- DRUG
-
TPN171H 10mg group
TPN171H 10mg taken orally on demand 0.5-4 hour prior to sexual intercourse
- DRUG
-
Placebo group
Placebo taken orally on demand 0.5-4 hour prior to sexual intercourse
Sponsors & Collaborators
-
Vigonvita Life Sciences
lead INDUSTRY
Principal Investigators
-
Hui Jiang · Peking University Third Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-31
- Primary Completion
- 2023-02-14
- Completion
- 2023-02-14
Countries
- China
Study Locations
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