Efficacy and Safety of TPN171H in the Patients With Erectile Dysfunction

NCT04479917 | Completed Phase 2

• 1 other identifier: TPN171H-E201
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 12

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.

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; TPN171H; Simmerafil

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 8

  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 .

  baseline and 8 weeks

• Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 8 in Percentage of Yes Responses

  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.

  baseline and 8 weeks

• Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 8 in Percentage of Yes Responses

  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.

  baseline and 8 weeks

Secondary Outcomes (9)

• Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions

  baseline ,4 weeks and 8 weeks

• Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF) ,Sexual Desire

  baseline ,4 weeks and 8 weeks

• Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF),Intercourse Satisfaction

  baseline ,4 weeks and 8 weeks

• Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction

  baseline ,4 weeks and 8 weeks

• Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 4 in Percentage of Yes Responses

  baseline and 4 weeks

Study Arms (4)

TPN171H 5mg group

EXPERIMENTAL

TPN171H 5mg tablet + Placebo 10mg 2 tablets

Drug: TPN171H

TPN171H 10mg group

EXPERIMENTAL

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

Drug: TPN171H

TPN171H 20mg group

EXPERIMENTAL

TPN171H 10mg 2 tablets + Placebo 5mg tablet

Drug: TPN171H

Placebo group

PLACEBO COMPARATOR

Placebo 5mg tablet+ Placebo 10mg 2 tablets

Drug: placebo

Interventions

TPN171H 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

Also known as: Simmerafil

TPN171H 10mg group; TPN171H 20mg group; TPN171H 5mg group

placebo 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

Eligibility Criteria

• Age: 22 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead
• Shanghai Institute of Materia Medica, Chinese Academy of Sciences: collaborator

Study Sites (12)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510000, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450100, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Second Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

The First Hospital of Jilin University

Changchun, Jinlin, 130021, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Hui Jiang, MD, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2020
• First Posted: July 21, 2020
• Study Start: July 23, 2020
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: June 22, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)