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Simmerafil (TPN171H) in Erectile Dysfunction
NCT05188989Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2021
- Primary completion
- Feb 2023
- Countries
- 1
- Sponsor
- Vigonvita Life Sciences
- Modality
- Small Molecules
- Drugs
- TPN171H
- Conditions
- erectile dysfunction (ED)
01
Overview
Phase 3, randomised, double-blind trial of TPN171H in erectile dysfunction (ED) (4 arms), sponsored by Vigonvita Life Sciences. Primary endpoints: Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12, Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses and 1 more. Started Dec 2021; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
TPN171H 2.5mg
Simmerafil 2.5mg on demand
TPN171H 5mg
Simmerafil 5mg on demand
TPN171H 10mg
Simmerafil 10mg on demand
Placebo
Placebo on demand
03
Who it enrols
Male patients 18-65 years old with erectile dysfunction for at least 6 months and IIEF-5 <= 21, in a stable heterosexual relationship. Excludes patients with significant cardiovascular disease, uncontrolled diabetes (HbA1c > 9%), or significant hepatic/renal dysfunction.
04
Endpoints
Primary
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Secondary
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 4, 8
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) >=26
Change From Baseline to 4 Week , 8 Week and 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions, Sexual Desire, Intercourse Satisfaction, Overall Satisfaction
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 4 in Percentage of Yes Responses
Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 4 in Percentage of Yes Responses
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