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Erectile DysfunctionPhase 2NCT01423370

Safety and Efficacy of YHD1023 in Erectile Dysfunction

A Phase 2 study testing YHD1023 and Cialis in people with Erectile Dysfunction, run by Yuhan Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
YHD1023 and Cialis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
1 siteSouth Korea
Study dates
Nov 2011to Mar 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yuhan Corporation

    Seoul, 156-754

Other trials in South Korea

About this study

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

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.

Being tested
YHD1023, Cialis, Placebo
Keywords
Erectile Dysfunction, YHD1023, YCD190, Cialis, Yuhan
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YHD1023Drug

    5g oral once daily

  • YHD1023Drug

    5g oral twice a day

  • YHD1023Drug

    10g oral once daily

  • CialisDrug

    5mg oral once daily

  • PlaceboDrug

    Oral

Study groups in NCT01423370
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Drug: YHD1023
Group BExperimentalNot described
Receives: Drug: YHD1023
Group CExperimentalNot described
Receives: Drug: YHD1023
Group DActive comparatorNot described
Receives: Drug: Cialis
Group EPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, Week 8

Secondary outcomes (5)

  1. 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).

    Measured: Baseline, Week 8

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

    Measured: Baseline, Week 8

  3. 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?

    Measured: Baseline, Week 8

  4. 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?

    Measured: Week 8

  5. Mean change in Life Satisfaction score

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01423370
Sponsor's protocol ID
YHD1023-201
Status last verified
May 2013
First submitted
24 Aug 2011
Last updated
31 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YHD1023 and Cialis in people with Erectile Dysfunction, run by Yuhan Corporation at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the International Index of Erectile Function(IIEF) - Erectile Function(EF) domain score at week 8 (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01423370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014.

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