Safety and Efficacy of YHD1023 in Erectile Dysfunction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01423370
First received: August 24, 2011
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Drug: YHD1023
Drug: Cialis
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Change from baseline in the International Index of Erectile Function(IIEF) - Erectile Function(EF) domain score at week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

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 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

    *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 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Percentage of Improved patients from baseline in Question 2 & Question 3 of Sexual Encounter Profile(SEP) at week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

    *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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    *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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: November 2011
Estimated Study Completion Date: July 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Drug: YHD1023
5g oral once daily
Experimental: Group B Drug: YHD1023
5g oral twice a day
Experimental: Group C Drug: YHD1023
10g oral once daily
Active Comparator: Group D Drug: Cialis
5mg oral once daily
Placebo Comparator: Group E Drug: Placebo
Oral

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423370

Locations
Korea, Republic of
Yuhan Corporation
Seoul, Korea, Republic of, 156-754
Sponsors and Collaborators
Yuhan Corporation
Investigators
Principal Investigator: Nam-Cheol Park, MD, PhD. Busan National University Hospital
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01423370     History of Changes
Other Study ID Numbers: YHD1023-201
Study First Received: August 24, 2011
Last Updated: May 13, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yuhan Corporation:
Erectile Dysfunction
YHD1023
YCD190
Cialis
Yuhan

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Tadalafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014