Safety and Efficacy of YHD1023 in Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YHD1023
YHD1023
YHD1023
Cialis
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, YHD1023, YCD190, Cialis, Yuhan
Eligibility Criteria
Inclusion Criteria:
- Male volunteers of aged 20 years and older with history of organic erectile dysfunction of at least 6 months duration
- Anticipate having the same adult female sexual partner, who have no possibility of being pregnant or breast-feeding and take steps to prevent conception during the study
- The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
- Have Erectile Function(EF) domain score 25 and under as the result of the International Index of Erectile Function(IIEF)
- Agree to make at least 4 sexual intercourse attempts on 4 separate days with the female sexual study party during the 4-week run-in period without medication and at least 50% of attempts during this period had been unsuccessful due to insufficient erection or unable to sustain penile rigidity until ejaculation
Exclusion Criteria:
- Have history of stroke, myocardial infarction, or Coronary Artery Bypass Graft surgery within the last 6 months
- Have history of cardiac failure, unstable angina, or life-threatening arrhythmia within the last 6 months
- Shown tachyarrhythmia, heart rate over 100 times/min(e.g. arterial fibrillation, flutter)
- Presence of hypotension as evidenced by SBP/DBP < 90/50mmHg or uncontrollable hypertension as evidenced by SBP/DBP > 170/100mmHg
- Presence of diagnosed diabetes(HbA1C > 12%)
- Have history of symptomatic postural hypotension within the last 6 months
- Have history of spinal cord injury, radical prostatectomy, or pelvic surgery
- Presence of penile anatomical deformities (e.g. severe penile fibrosis or Peyronie's disease)
- Presence of hypogonadism(serum total testosterone under the reference lowest limit)
- Presence of hepatic impairment(AST or ALT > 3 times of normal upper limit) or renal impairment(serum creatinine ≥ 2.5mg/dl)
- Have history of severe gastrointestinal hemorrhage within the last 1 year
- Have history of hematodyscrasia predisposing to priapism(e.g. sickle cell disease, multiple myeloma, or leukemia) or bleeding disorder
- Subject who is judged to be ineligible according to their physical checkup(medical history, physical examination, ECG, laboratory values and etc.) within 56 days prior to the first administration
- Concomitant use of one or more of nitrates/nitric oxide(NO) donor(e.g. nitroglycerine, isosorbid, mononitrate, isosorbid dinitrate, amylnitrate/nitrite, sodium nitroprusside), Trazodone, cancer chemotherapy, anticoagulants, androgens, or anti-androgens
- Use of any PDE-5 inhibitor(e.g. Viagra, Levitra, Cialis, Yaila, or Zydena), vasodilator self-injection, or other treatments for erectile dysfunction within the last 2 weeks prior to the study
- Participated in any other clinical trials within 30 days prior to the first administration
- Have history of primary hypoactive sexual desire
- Subject who is judged to be ineligible by principal investigator or sub-investigator due to mental disorder or continuous drug abuse
Sites / Locations
- Yuhan Corporation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Group A
Group B
Group C
Group D
Group E
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in the International Index of Erectile Function(IIEF) - Erectile Function(EF) domain score at week 8
Secondary Outcome Measures
Percentage of Improved patients from baseline in Question 3 & Question 4 of the International Index of Erectile Function(IIEF) at week 8
*Improved: Score increased 1 or more compared to the baseline score
Question 3: How many times were you able to insert your penis into your partner's vagina? Scores range from 0(did not have sexual intercourse) to 5(always or most times).
Question 4: How many times did your erection last long enough for you to complete intercourse? Scores range from 0(did not have sexual intercourse) to 5(always or most times).
Mean change from baseline in other Question of International Index of Erectile Function(IIEF) domain at week 8
Percentage of Improved patients from baseline in Question 2 & Question 3 of Sexual Encounter Profile(SEP) at week 8
*Improved: Response change from "No" at baseline to "Yes" at week 8
Question 2: Were you able to insert your penis into your partner's vagina?
Question 3: Did your erection last long enough for you to complete intercourse with ejaculation?
Percentage of Improved patients from baseline in Global Assessment Question(GAQ) at week 8
*Improved: Yes response at week 8
GAQ: Did the 4 week treatment improve you ability to achieve and maintain your erection?
Mean change in Life Satisfaction score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01423370
Brief Title
Safety and Efficacy of YHD1023 in Erectile Dysfunction
Official Title
Multi-center, Randomized, Double-blind, Placebo/Active-controlled, Phase II Clinical Trial to Assess the Safety and Efficacy of YHD1023 in Patients With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to assess the safety and efficacy of oral YHD1023 5g or 10g on erectile dysfunction to investigate the optimal recommended dosage. Study period is 12 weeks including 4weeks of follow-up period without treatment. Study patients will fill in the international index of erectile function questionnaire and life satisfaction questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile Dysfunction, YHD1023, YCD190, Cialis, Yuhan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Experimental
Arm Title
Group D
Arm Type
Active Comparator
Arm Title
Group E
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
YHD1023
Intervention Description
5g oral once daily
Intervention Type
Drug
Intervention Name(s)
YHD1023
Intervention Description
5g oral twice a day
Intervention Type
Drug
Intervention Name(s)
YHD1023
Intervention Description
10g oral once daily
Intervention Type
Drug
Intervention Name(s)
Cialis
Intervention Description
5mg oral once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Change from baseline in the International Index of Erectile Function(IIEF) - Erectile Function(EF) domain score at week 8
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Percentage of Improved patients from baseline in Question 3 & Question 4 of the International Index of Erectile Function(IIEF) at week 8
Description
*Improved: Score increased 1 or more compared to the baseline score
Question 3: How many times were you able to insert your penis into your partner's vagina? Scores range from 0(did not have sexual intercourse) to 5(always or most times).
Question 4: How many times did your erection last long enough for you to complete intercourse? Scores range from 0(did not have sexual intercourse) to 5(always or most times).
Time Frame
Baseline, Week 8
Title
Mean change from baseline in other Question of International Index of Erectile Function(IIEF) domain at week 8
Time Frame
Baseline, Week 8
Title
Percentage of Improved patients from baseline in Question 2 & Question 3 of Sexual Encounter Profile(SEP) at week 8
Description
*Improved: Response change from "No" at baseline to "Yes" at week 8
Question 2: Were you able to insert your penis into your partner's vagina?
Question 3: Did your erection last long enough for you to complete intercourse with ejaculation?
Time Frame
Baseline, Week 8
Title
Percentage of Improved patients from baseline in Global Assessment Question(GAQ) at week 8
Description
*Improved: Yes response at week 8
GAQ: Did the 4 week treatment improve you ability to achieve and maintain your erection?
Time Frame
Week 8
Title
Mean change in Life Satisfaction score
Time Frame
Week 8
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male volunteers of aged 20 years and older with history of organic erectile dysfunction of at least 6 months duration
Anticipate having the same adult female sexual partner, who have no possibility of being pregnant or breast-feeding and take steps to prevent conception during the study
The patient or legally authorized representative must sign a written informed consent, prior to the any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
Have Erectile Function(EF) domain score 25 and under as the result of the International Index of Erectile Function(IIEF)
Agree to make at least 4 sexual intercourse attempts on 4 separate days with the female sexual study party during the 4-week run-in period without medication and at least 50% of attempts during this period had been unsuccessful due to insufficient erection or unable to sustain penile rigidity until ejaculation
Exclusion Criteria:
Have history of stroke, myocardial infarction, or Coronary Artery Bypass Graft surgery within the last 6 months
Have history of cardiac failure, unstable angina, or life-threatening arrhythmia within the last 6 months
Shown tachyarrhythmia, heart rate over 100 times/min(e.g. arterial fibrillation, flutter)
Presence of hypotension as evidenced by SBP/DBP < 90/50mmHg or uncontrollable hypertension as evidenced by SBP/DBP > 170/100mmHg
Presence of diagnosed diabetes(HbA1C > 12%)
Have history of symptomatic postural hypotension within the last 6 months
Have history of spinal cord injury, radical prostatectomy, or pelvic surgery
Presence of penile anatomical deformities (e.g. severe penile fibrosis or Peyronie's disease)
Presence of hypogonadism(serum total testosterone under the reference lowest limit)
Presence of hepatic impairment(AST or ALT > 3 times of normal upper limit) or renal impairment(serum creatinine ≥ 2.5mg/dl)
Have history of severe gastrointestinal hemorrhage within the last 1 year
Have history of hematodyscrasia predisposing to priapism(e.g. sickle cell disease, multiple myeloma, or leukemia) or bleeding disorder
Subject who is judged to be ineligible according to their physical checkup(medical history, physical examination, ECG, laboratory values and etc.) within 56 days prior to the first administration
Concomitant use of one or more of nitrates/nitric oxide(NO) donor(e.g. nitroglycerine, isosorbid, mononitrate, isosorbid dinitrate, amylnitrate/nitrite, sodium nitroprusside), Trazodone, cancer chemotherapy, anticoagulants, androgens, or anti-androgens
Use of any PDE-5 inhibitor(e.g. Viagra, Levitra, Cialis, Yaila, or Zydena), vasodilator self-injection, or other treatments for erectile dysfunction within the last 2 weeks prior to the study
Participated in any other clinical trials within 30 days prior to the first administration
Have history of primary hypoactive sexual desire
Subject who is judged to be ineligible by principal investigator or sub-investigator due to mental disorder or continuous drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Cheol Park, MD, PhD.
Organizational Affiliation
Busan National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yuhan Corporation
City
Seoul
ZIP/Postal Code
156-754
Country
Korea, Republic of
12. IPD Sharing Statement
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Safety and Efficacy of YHD1023 in Erectile Dysfunction
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