Clinical trial NCT01423370: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
YHD1023
YCD190
Cialis
Yuhan
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-25
Enrollment: 104
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in the International Index of Erectile Function(IIEF) - Erectile Function(EF) domain score at week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Percentage of Improved patients from baseline in Question 3 & Question 4 of the International Index of Erectile Function(IIEF) at week 8
timeFrame: Baseline, Week 8
measure: Mean change from baseline in other Question of International Index of Erectile Function(IIEF) domain at week 8
timeFrame: Baseline, Week 8
measure: Percentage of Improved patients from baseline in Question 2 & Question 3 of Sexual Encounter Profile(SEP) at week 8
timeFrame: Baseline, Week 8
measure: Percentage of Improved patients from baseline in Global Assessment Question(GAQ) at week 8
timeFrame: Week 8
measure: Mean change in Life Satisfaction score
timeFrame: Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yuhan Corporation
Study officials:
affiliation: Busan National University Hospital
name: Nam-Cheol Park, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: