Erectile Dysfunction
Conditions
Brief summary
This is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction.
Interventions
DRUGTPN171H
10 mg/ time, as needed, it is recommended to take warm water within 0.5 to 4 hours before sexual activity.
Sponsors
Vigonvita Life Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 years to 75 years (inclusive); * Males with ED at least 3 months; * IIEF-5 ≤ 21 at visit 1; * Patients in a stable, heterosexual relationship during the study; * 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≤25. * Patients who are willing to have 4 or more attempts of sexual intercourse per month, 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 last dose; * 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 do not respond to marketed PDE5 inhibitors or have adverse reactions that lead to drug discontinuation; * CYP3A4 potent inhibitors, moderate inhibitors, and potent inducers need to be used during the trial or discontinued for less than 31 days before enrollment; * Subjects who are taking nitrate or NO donor drugs, guanylate cyclase agonists and cannot be discontinued during the trial; * Patients with the following cardiovascular disease: Myocardial infarction or stroke within the last 6 months; Unstable angina or angina occurring during sexual intercourse; New York Heart Association Class 2 or greater heart failure in the last 6 months; * Uncontrolled hypotension (\<90/60mmHg) or uncontrolled hypertension (≥180/110mmHg); * Patients with diabetic complications (diabetic nephropathy, peripheral neuropathy); * Patients with hepatic or renal dysfunction as per the following: AST, ALT\>3\*ULN, serum creatinine exceeds 50% of the upper limit of normal value; * Patients with active gastrointestinal ulcers and bleeding disorders; * Patients who have a history of NAION, or with a known genetically degenerative retinopathy, including retinitis pigmentosa; * Patients who have a history of sudden decrease or loss of hearing; * Patients with a history of severe central nervous system injury or peripheral muscular neurological disease in the past 6 months; * Patient with a history of malignancy; * Patients with significant neurological abnormalities who are unable or unwilling to cooperate; * Patients whose partner is breastfeeding/pregnant/trying to become pregnant, has a gynecological disease or is restricted in their activities during treatment; * Patients who have used other drugs in clinical trials within the last 1 month; * For other reasons besides the aforementioned cases, patient whose participation is deemed inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AE) and adverse drug reactions (ADRs) during treatment observation. | during the treatment and observation. | Adverse events occurring throughout the study period were assessed and graded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd and 6th month in Percentage of Yes Responses. | baseline，3 months, 6 months | 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 the 3rd and 6th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses. | baseline，3 months, 6 months | 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. |
| Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the 3rd and 6th month of medication. | baseline，3 months, 6 months | Assessed was the changes in the number of subjects whose IIEF domain score at the 6th month visit was ≥26. |
| Change From Baseline to the 3rd months and 6th months Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction. | baseline，3 months, 6 months | Self-reported, Orgasmic Functions, Sexual Desire, Intercourse Satisfaction, Overall Satisfaction. |
| Percentage of respondents who answered yes to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd and 6th month. | 3 months, 6 months | Percentage of respondents who answered yes to questions 1 and 2 of the GAQ. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity? The data is expressed as the average percentage of yes answers per participant. |
| Change From Baseline in the International Index of Erectile Function - Erectile Function. | baseline，3 months, 6 months | 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 3 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responsesat Week 12 in Percentage of Yes Responses. | baseline，3 months, 6 months, 9 months and 12 months | 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. |
| Percentage of subjects whose IIEF-EF scores returned to normal (≥26) at the the 3rd，6th，9th，12th month of medication. | baseline，3 months, 6 months, 9 months and 12 months | Assessed was the changes in the number of subjects whose IIEF domain score at the 3rd，6th，9th，12th month visit was ≥26. |
| Change From Baseline to the 3rd，6th，9th，12th month Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions,Sexual Desire,Intercourse Satisfaction, Overall Satisfaction. | baseline, 3 months, 6 months, 9 months and 12 months | Self-reported, Orgasmic Functions, Sexual Desire, Intercourse Satisfaction, Overall Satisfaction. |
| Percentage of respondents who answered yes to questions 1 and 2 of the Comprehensive Evaluation Questionnaire (GAQ) at 3 Erectile Function (IIEF),Orgasmicand at the 3rd，6th，9th，12th month . | 3 months, 6 months, 9 months and 12 months | Percentage of respondents who answered yes to questions 1 and 2 of the GAQ. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity? The data is expressed as the average percentage of yes answers per participant. |
| Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at the 3rd，6th，9th，12th month in Percentage of Yes Responses. | baseline，3 months, 6 months, 9 months and 12 months | 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. |
Countries
China
Outcome results
None listed