Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    740
  • sponsor
    Vigonvita Life Sciences
Updated on 25 March 2022
sham treatment

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.

Details
Condition Erectile Dysfunction
Treatment Placebo group, TPN171H 2.5mg group, TPN171H 5mg group, TPN171H 10mg group
Clinical Study IdentifierNCT05188989
SponsorVigonvita Life Sciences
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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≤25
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
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), uncontrolled hypertension (≥160/95mmHg); Orthostatic hypotension
Diabetic patients whose FBS is over 1.5 fold of normal value, or whose HbA1c >9%, or with diabetes complications, such as diabetic nephropathy, peripheral neuropathy
Patients with hepatic or renal dysfunction as per the following: AST, ALT>2ULN, serum creatinine exceeds 20% 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
Patients with alcohol addiction
Patients with persistent abuse of drugs of dependence
Patients who are planning to father a baby or are in a relationship with a pregnant partner
Patients who have a childbirth plan during the trial period and within 3 months after the trial
Patients who are participating in the past 3 months from any other clinical trial
For other reasons besides the aforementioned cases, patient whose participation is deemed inappropriate due to clinically significant findings according to the medical decision of the principal investigator or the study personnel
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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