Efficacy and Safety of TPN171H in the Patients With Erectile Dysfunction

NCT ID: NCT04479917

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-23
• Study Completion Date: 2021-07-26

Brief Summary

This is an exploratory clinical study to presume the optimum usage and dosage for a therapeutic confirmatory study by evaluating the efficacy and safety of TPN171H 5mg, 10mg, 20mg or placebo administered orally in patients with erectile dysfunction. In conclusions, Patients with erectile dysfunction (ED) were administered placebo, TPN171H 5mg, 10mg or 20mg 30 minutes to 4 hours before sexual intercourse for 8 weeks.

Detailed Description

This is a Phase II study in 240 ED patients, which consists of 3 part: 1) a 4-week run-in period without any ED treatment; 2)randomization to 8 weeks of treatment with TPN171H or placebo; and 3) a 1-week follow-up period for continued adverse event monitoring.

The effects of TPN171H on ED will be evaluated using the IIEF-EF and SEP diaries. The IIEF-EF will be administered at baseline and at 4-week intervals following initiation of treatment, meanwhile the SEP diary will be completed by patients after each sexual attempt throughout the study.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TPN171H 5mg group

TPN171H 5mg tablet + Placebo 10mg 2 tablets

Group Type: EXPERIMENTAL

TPN171H

Intervention Type: DRUG

Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period

TPN171H 10mg group

TPN171H 10mg tablet + Placebo 5mg tablet+ Placebo 10mg tablet

Group Type: EXPERIMENTAL

TPN171H

Intervention Type: DRUG

Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period

TPN171H 20mg group

TPN171H 10mg 2 tablets + Placebo 5mg tablet

Group Type: EXPERIMENTAL

TPN171H

Intervention Type: DRUG

Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period

Placebo group

Placebo 5mg tablet+ Placebo 10mg 2 tablets

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period

Interventions

TPN171H

Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period

Intervention Type: DRUG

placebo

Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period

Intervention Type: DRUG

Other Intervention Names

Simmerafil

Eligibility Criteria

Inclusion Criteria

• Male patients aged ≥22 with ED, defined as an inability to achieve or maintain a penile erection sufficient for satisfactory sexual intercourse, evident for at least 3 months;
• Patients whose IIEF-EF domain score is < 26;
• 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 each 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 study completed;
• Patients who have voluntarily decided to participate in this study, and signed the informed consent form.

Exclusion Criteria

• 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, like hypopituitarism, hypothyroidism, or hypogonadism.
• 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 a history of hypersensitivity to other PDE5 inhibitors or who have not responded to them;
• 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 (≥160/95mmHg); Orthostatic hypotension.

• Patients administered with the following medications:

Nitrate/Nitric oxide (NO) donors; Androgens, anti-androgen, trazodone; Agents that significantly affect the CYP3A4 intermediary metabolism.

• Diabetic patients whose FBS is over 1.5 fold of normal value, or whose HbA1c exceeds 9%, or with diabetes complications, such as diabetic nephropathy, peripheral neuropathy;
• Patients with hepatic or renal dysfunction as per the following: AST, ALT≧2*ULN, 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;
• Patient with a history of malignancy;
• Patients with a major refractory psychiatric disorder or significant neurological abnormalities;
• Patients with alcohol addiction or persistent abuse of drugs of dependence;
• Patients who are participating or discontinued participation in the past 3 months from any other clinical trial, or are planning to father a baby or are in a relationship with a pregnant partner.
• 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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Institute of Materia Medica, Chinese Academy of Sciences

OTHER

Sponsor Role: collaborator

Vigonvita Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Jiang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Second Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jinlin, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Countries

China

Other Identifiers

TPN171H-E201

Identifier Type: -

Identifier Source: org_study_id