Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile Dysfunction (NCT07692867) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study of Tunodafil Hydrochloride Tablets in Erectile Dysfunction
China780 participantsStarted 2021-04-01
Plain-language summary
This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of Tunodafil Hydrochloride Tablets in men with erectile dysfunction.
Who can participate
Age range
18 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Male subjects aged between 18 and 65 years (inclusive) diagnosed with Erectile Dysfunction (ED).
* At Visit 1, subjects must have an International Index of Erectile Function-5 (IIEF-5) score ≤ 21, with a disease duration of at least 6 months.
* Subjects must have a stable marital relationship or a stable female sexual partner for at least 3 months prior to screening and throughout the study period.
* Subjects must agree to attempt sexual intercourse at least 4 times per visit cycle.
* Subjects agree not to use any other ED treatments during the study, including PDE5 inhibitors, traditional Chinese medicine (including decoctions and patent medicines), or medical devices for ED treatment.
* Subjects (and their partners) must have no plans for conception from the time of screening up to 3 months after the last dose, and must voluntarily use effective contraceptive measures.
* Subjects must voluntarily provide written informed consent.
* Upon completion of the run-in period, subjects must meet all of the following three conditions:
* At least 4 sexual intercourse attempts were made during the run-in period; ② The failure rate of sexual intercourse attempts was ≥ 50% (failure defined as at least one "No" answer to the first three questions of the Sexual Encounter Profile \[SEP\] diary); ③ The IIEF-Erectile Function (IIEF-EF) domain score was ≥ 5 and ≤ 25.
Exclusion Criteria:
* \- Subjects with obvious congenital malformations or anatomical abnormalit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Timeframe: baseline and 12 weeks
2
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Timeframe: baseline and 12 weeks
3
Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Timeframe: baseline and 12 weeks
Trial details
NCT IDNCT07692867
SponsorYangtze River Pharmaceutical Group Co., Ltd.