Safety and Efficacy of YHD1023 in Erectile Dysfunction - Full Text View

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:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Tadalafil

U.S. FDA Resources

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 May 16, 2013