Safety and Efficacy of YHD1023 in Erectile Dysfunction

NCT01423370 | Completed Phase 2 DMC

• 1 other identifier: YHD1023-201
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; YHD1023; YCD190; Cialis; Yuhan

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the International Index of Erectile Function(IIEF) - Erectile Function(EF) domain score at week 8

  Baseline, Week 8

Secondary Outcomes (5)

• Percentage of Improved patients from baseline in Question 3 & Question 4 of the International Index of Erectile Function(IIEF) at week 8

  Baseline, Week 8

• Mean change from baseline in other Question of International Index of Erectile Function(IIEF) domain at week 8

  Baseline, Week 8

• Percentage of Improved patients from baseline in Question 2 & Question 3 of Sexual Encounter Profile(SEP) at week 8

  Baseline, Week 8

• Percentage of Improved patients from baseline in Global Assessment Question(GAQ) at week 8

  Week 8

• Mean change in Life Satisfaction score

  Week 8

Study Arms (5)

Group A

EXPERIMENTAL

Drug: YHD1023

Group B

EXPERIMENTAL

Drug: YHD1023

Group C

EXPERIMENTAL

Drug: YHD1023

Group D

ACTIVE COMPARATOR

Drug: Cialis

Group E

PLACEBO COMPARATOR

Drug: Placebo

Interventions

YHD1023 DRUG

5g oral once daily

Group A

Cialis DRUG

5mg oral once daily

Group D

Placebo DRUG

Oral

Group E

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Yuhan Corporation

Seoul, 156-754, South Korea

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Nam-Cheol Park, MD, PhD.

  Busan National University 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: August 24, 2011
• First Posted: August 25, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 31, 2014

Record last verified: 2013-05

Locations

KR (1)