A Multi-Center ,Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of TPN171H in Patients With Erectile Dysfunction
Overview
- Phase
- Phase 3
- Intervention
- TPN171H 2.5mg group
- Conditions
- Erectile Dysfunction
- Sponsor
- Vigonvita Life Sciences
- Enrollment
- 765
- Locations
- 49
- Primary Endpoint
- Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years to 65 years (inclusive)
- •Males with ED at least 6 months
- •IIEF-5 ≤ 21 at visit 1
- •Patients in a stable, heterosexual relationship for at least 3 months and during the study;
- •Patients who are willing to stay away from any other medicines or treatments for ED during this study period
- •Patients who are willing to have 4 or more attempts of sexual intercourse per 4 weeks, demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
- •Patients who are willing to take proper contraceptive during the study and within 3 months after the study completed;
- •At the end of the untreated baseline period, the following conditions are met：（1）The subject must make at least four attempts at sexual intercourse during the untreated baseline period. （2）At least 50% of attempts during this period must be unsuccessful,（unsuccess means at least one of the first three questions should be answered "No" in SEP）.（3）5≤IIEF-EF≤
- •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
TPN171H 2.5mg group
Intervention: TPN171H 2.5mg group
TPN171H 5mg group
Intervention: TPN171H 5mg group
TPN171H 10mg group
Intervention: TPN171H 10mg group
Placebo group
Intervention: Placebo group
Outcomes
Primary Outcomes
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Time Frame: baseline and 12 weeks
The primary efficacy variable was the change in the EF domain scores of the IIEF questionnaire from baseline, calculated by comparing total scores from questions 1-5 and 15 from the IIEF questionnaire .
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Time Frame: baseline and 12 weeks
Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. "Were you able to insert your penis into your partner's vagina when you are trying to have sex ?" Data are presented as the mean percentage of yes responses per participant.
Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Time Frame: baseline and 12 weeks
Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per participant.
Secondary Outcomes
- Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 4、8(baseline ,4 weeks and 8 weeks)
- Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 4、8、12(baseline , 4 weeks , 8 weeks ,12 weeks)
- Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 4 in Percentage of Yes Responses(baseline , 4 weeks , 8 weeks)
- 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(baseline , 4 weeks , 8 weeks ,12 weeks)
- Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 4 in Percentage of Yes Responses(baseline , 4 weeks , 8 weeks)