<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04479917</url>
  </required_header>
  <id_info>
    <org_study_id>TPN171H-E201</org_study_id>
    <nct_id>NCT04479917</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of TPN171H in the Patients With Erectile Dysfunction</brief_title>
  <official_title>A Multi-Center ,Randomized, Double-Blind, Placebo-Controlled, Dose-Exploring Study to Evaluate the Efficacy and Safety of TPN171H in China Male Patients With Erectile Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vigonvita Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Institute of Materia Medica, Chinese Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vigonvita Life Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an exploratory clinical study to presume the optimum usage and dosage for a&#xD;
      therapeutic confirmatory study by evaluating the efficacy and safety of TPN171H 5mg, 10mg,&#xD;
      20mg or placebo administered orally in patients with erectile dysfunction. In conclusions,&#xD;
      Patients with erectile dysfunction (ED) were administered placebo, TPN171H 5mg, 10mg or 20mg&#xD;
      30 minutes to 4 hours before sexual intercourse for 8 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase II study in 240 ED patients, which consists of 3 part: 1) a 4-week run-in&#xD;
      period without any ED treatment; 2)randomization to 8 weeks of treatment with TPN171H or&#xD;
      placebo; and 3) a 1-week follow-up period for continued adverse event monitoring.&#xD;
&#xD;
      The effects of TPN171H on ED will be evaluated using the IIEF-EF and SEP diaries. The IIEF-EF&#xD;
      will be administered at baseline and at 4-week intervals following initiation of treatment,&#xD;
      meanwhile the SEP diary will be completed by patients after each sexual attempt throughout&#xD;
      the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Actual">July 26, 2021</completion_date>
  <primary_completion_date type="Actual">July 26, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 8</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>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 .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 8 in Percentage of Yes Responses</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. &quot;Were you able to insert your penis into your partner's vagina when you are trying to have sex ?&quot; Data are presented as the mean percentage of yes responses per participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 8 in Percentage of Yes Responses</measure>
    <time_frame>baseline and 8 weeks</time_frame>
    <description>Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. &quot;Did your erection last long enough for you to have successful intercourse?&quot; Data are presented as the mean percentage of yes responses per participant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions</measure>
    <time_frame>baseline ,4 weeks and 8 weeks</time_frame>
    <description>Self-reported Orgasmic Functions over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF) ,Sexual Desire</measure>
    <time_frame>baseline ,4 weeks and 8 weeks</time_frame>
    <description>Self-reported Sexual Desire over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF),Intercourse Satisfaction</measure>
    <time_frame>baseline ,4 weeks and 8 weeks</time_frame>
    <description>Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction</measure>
    <time_frame>baseline ,4 weeks and 8 weeks</time_frame>
    <description>Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 4 in Percentage of Yes Responses</measure>
    <time_frame>baseline and 4 weeks</time_frame>
    <description>Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. &quot;Were you able to insert your penis into your partner's vagina?&quot; Data are presented as the mean percentage of yes responses per participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 4 in Percentage of Yes Responses</measure>
    <time_frame>baseline and 4 weeks</time_frame>
    <description>Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. &quot;Did your erection last long enough for you to have successful intercourse?&quot; Data are presented as the mean percentage of yes responses per participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 8</measure>
    <time_frame>baseline ,4 weeks and 8 weeks</time_frame>
    <description>Assessed was the changes in the number of subjects whose IIEF domain score at the 8th week visit was ≥26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subgroup analysis based on ED severity categories: severe,0-10; moderate,11-16; mild,17-25.</measure>
    <time_frame>baseline ,4 weeks and 8 weeks</time_frame>
    <description>Subgroup analysis based on ED severity categories: severe,0-10; moderate,11-16; mild,17-25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subgroup analysis based on the time intervals between meal and medication.</measure>
    <time_frame>baseline ,4 weeks and 8 weeks</time_frame>
    <description>Subgroup analysis based on the time intervals between meal and medication.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">255</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>TPN171H 5mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TPN171H 5mg tablet + Placebo 10mg 2 tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TPN171H 10mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TPN171H 10mg tablet + Placebo 5mg tablet+ Placebo 10mg tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TPN171H 20mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TPN171H 10mg 2 tablets + Placebo 5mg tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 5mg tablet+ Placebo 10mg 2 tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TPN171H</intervention_name>
    <description>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</description>
    <arm_group_label>TPN171H 10mg group</arm_group_label>
    <arm_group_label>TPN171H 20mg group</arm_group_label>
    <arm_group_label>TPN171H 5mg group</arm_group_label>
    <other_name>Simmerafil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>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</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patients aged ≥22 with ED, defined as an inability to achieve or maintain a&#xD;
             penile erection sufficient for satisfactory sexual intercourse, evident for at least 3&#xD;
             months;&#xD;
&#xD;
          -  Patients whose IIEF-EF domain score is &lt; 26;&#xD;
&#xD;
          -  Patients in a stable, heterosexual relationship for at least 3 months and during the&#xD;
             study;&#xD;
&#xD;
          -  Patients who are willing to stay away from any other medicines or treatments for ED&#xD;
             during this study period;&#xD;
&#xD;
          -  Patients who are willing to have 4 or more attempts of sexual intercourse each month,&#xD;
             demonstrated compliance with the study protocol, including drug administration, diary&#xD;
             completion, and scheduled study visits, during the qualifying trial;&#xD;
&#xD;
          -  Patients who are willing to take proper contraceptive during the study and within 3&#xD;
             months after the study completed;&#xD;
&#xD;
          -  Patients who have voluntarily decided to participate in this study, and signed the&#xD;
             informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with anatomical malformations of the penis;&#xD;
&#xD;
          -  Patients with primary hypoactive sexual desire;&#xD;
&#xD;
          -  Patients with ED, which is caused by any other primary sexual disorder, like&#xD;
             hypopituitarism, hypothyroidism, or hypogonadism.&#xD;
&#xD;
          -  Patients with ED ,which is caused by spinal injury or have had a radical prostatectomy&#xD;
             or other surgery ;&#xD;
&#xD;
          -  Patients who have a penile implant;&#xD;
&#xD;
          -  Patients who have a history of hypersensitivity to other PDE5 inhibitors or who have&#xD;
             not responded to them;&#xD;
&#xD;
          -  Patients with the following cardiovascular disease:&#xD;
&#xD;
        Myocardial infarction or stroke within the last 6 months; Unstable angina or angina&#xD;
        occurring during sexual intercourse; New York Heart Association Class 2 or greater heart&#xD;
        failure in the last 6 months; Uncontrolled hypotension (&lt;90/60mmHg), or uncontrolled&#xD;
        hypertension (≥160/95mmHg); Orthostatic hypotension.&#xD;
&#xD;
          -  Patients administered with the following medications:&#xD;
&#xD;
        Nitrate/Nitric oxide (NO) donors; Androgens, anti-androgen, trazodone; Agents that&#xD;
        significantly affect the CYP3A4 intermediary metabolism.&#xD;
&#xD;
          -  Diabetic patients whose FBS is over 1.5 fold of normal value, or whose HbA1c exceeds&#xD;
             9%, or with diabetes complications, such as diabetic nephropathy, peripheral&#xD;
             neuropathy;&#xD;
&#xD;
          -  Patients with hepatic or renal dysfunction as per the following: AST, ALT≧2*ULN, serum&#xD;
             creatinine exceeds 20% of the upper limit of normal value;&#xD;
&#xD;
          -  Patients with active gastrointestinal ulcers and bleeding disorders;&#xD;
&#xD;
          -  Patients who have a history of NAION, or with a known genetically degenerative&#xD;
             retinopathy, including retinitis pigmentosa;&#xD;
&#xD;
          -  Patients who have a history of sudden decrease or loss of hearing;&#xD;
&#xD;
          -  Patient with a history of malignancy;&#xD;
&#xD;
          -  Patients with a major refractory psychiatric disorder or significant neurological&#xD;
             abnormalities;&#xD;
&#xD;
          -  Patients with alcohol addiction or persistent abuse of drugs of dependence;&#xD;
&#xD;
          -  Patients who are participating or discontinued participation in the past 3 months from&#xD;
             any other clinical trial, or are planning to father a baby or are in a relationship&#xD;
             with a pregnant partner.&#xD;
&#xD;
          -  For other reasons besides the aforementioned cases, patient whose participation is&#xD;
             deemed inappropriate due to clinically significant findings according to the medical&#xD;
             decision of the principal investigator or the study personnel.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hui Jiang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Fujian Medical University</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou First People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Shenzhen Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518036</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Suzhou University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jinlin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Erectile Dysfunction</keyword>
  <keyword>TPN171H</keyword>
  <keyword>Simmerafil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04479917
org study id: TPN171H-E201
nct id: NCT04479917
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 8
time frame: baseline and 8 weeks
description: 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 .
measure: Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 8 in Percentage of Yes Responses
time frame: baseline and 8 weeks
description: 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.
measure: Change From Baseline in Question 3 of the Patient Sexual Encounter Profile (SEP) Diary at Week 8 in Percentage of Yes Responses
time frame: baseline and 8 weeks
description: 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.
measure: Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF),Orgasmic Functions
time frame: baseline ,4 weeks and 8 weeks
description: Self-reported Orgasmic Functions over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.
measure: Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF) ,Sexual Desire
time frame: baseline ,4 weeks and 8 weeks
description: Self-reported Sexual Desire over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.
measure: Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF),Intercourse Satisfaction
time frame: baseline ,4 weeks and 8 weeks
description: Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
measure: Change From Baseline to 4 Week and 8 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction
time frame: baseline ,4 weeks and 8 weeks
description: Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
measure: Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 4 in Percentage of Yes Responses
time frame: baseline and 4 weeks
description: 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?" Data are presented as the mean percentage of yes responses per participant.
measure: Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 4 in Percentage of Yes Responses
time frame: baseline and 4 weeks
description: 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.
measure: Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) ≥26 at Week 8
time frame: baseline ,4 weeks and 8 weeks
description: Assessed was the changes in the number of subjects whose IIEF domain score at the 8th week visit was ≥26.
measure: Subgroup analysis based on ED severity categories: severe,0-10; moderate,11-16; mild,17-25.
time frame: baseline ,4 weeks and 8 weeks
description: Subgroup analysis based on ED severity categories: severe,0-10; moderate,11-16; mild,17-25.
measure: Subgroup analysis based on the time intervals between meal and medication.
time frame: baseline ,4 weeks and 8 weeks
description: Subgroup analysis based on the time intervals between meal and medication.
arm group label: TPN171H 5mg group
arm group type: Experimental
description: TPN171H 5mg tablet + Placebo 10mg 2 tablets
arm group label: TPN171H 10mg group
arm group type: Experimental
description: TPN171H 10mg tablet + Placebo 5mg tablet+ Placebo 10mg tablet
arm group label: TPN171H 20mg group
arm group type: Experimental
description: TPN171H 10mg 2 tablets + Placebo 5mg tablet
arm group label: Placebo group
arm group type: Placebo Comparator
description: Placebo 5mg tablet+ Placebo 10mg 2 tablets
intervention type: Drug
intervention name: TPN171H
description: 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
arm group label: TPN171H 10mg group
arm group label: TPN171H 20mg group
arm group label: TPN171H 5mg group
other name: Simmerafil
intervention type: Drug
intervention name: placebo
description: 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
arm group label: Placebo group
criteria: 
gender: Male
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Hui Jiang, MD, PhD
role: Principal Investigator
affiliation: Peking University Third Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Erectile Dysfunction
sharing ipd: No