NCT01305083

Brief Summary

This randomized, double blind, placebo controlled, multicentric, clinical study will assess the efficacy and safety of Udenafil (100 mg) tablets in patients suffering from erectile dysfunction(ED).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

10 months

First QC Date

February 25, 2011

Last Update Submit

May 11, 2012

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • IIEF

    8 week

Secondary Outcomes (3)

  • Changes in the total score of IIEF at the end of the treatment compared to baseline.

    8 week

  • Changes in score of Question 3 (SEP2) and Question 4 (SEP3) of IIEF questionnaire at the end of the treatment period as compared to baseline.

    8 week

  • Overall assessment of efficacy (GAQ) to the study medication at the end of the study.

    8 week

Study Arms (2)

Udenafil

ACTIVE COMPARATOR

Active Ingredient

Drug: UdenafilDrug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo

Drug: UdenafilDrug: Placebo

Interventions

UdenafilDRUG

Placebo-control

PlaceboUdenafil
PlaceboDRUG

Placebo

PlaceboUdenafil

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male patients of 18 to 60 years of age.
  • Patients in a stable, monogamous sexual relationship with a female partner for at least 6 months and willing to maintain this relationship for the duration of the study.
  • Patients with established diagnosis of erectile dysfunction (ED) of organic, psychogenic or mixed etiology for at least 6 months duration.
  • Patient willing to attempt at least one sexual intercourse in a week for the entire treatment.

You may not qualify if:

  • Patients with total erectile failure or any other sexual disorder such as hypoactive sexual desire.
  • Patients who have previously failed to respond to PDE-5 inhibitors like Sildenafil, Vardenafil or Tadalafil.
  • Patients who have used other erectile dysfunction therapies within 14 days (2 weeks) prior to entering into this study (i.e. visit 1).
  • Patients with hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease or penile trauma.
  • Patients with a history of major psychiatric disorder.
  • Patients with a history of significant pathological cardiovascular conditions such as: congestive heart failure, life-threatening arrhythmia or ischemic heart disease within the past 6 months.
  • Patients with a history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or a radical prostatectomy or radical pelvic surgery.
  • Patients with hypotension (\<90/50) or uncontrolled hypertension (\>170/100), uncontrolled diabetes, hepatic impairment (SGOT or SGPT levels \> 3 x Upper Normal Limit), renal impairment (serum creatinine \> 2.5mg/dl), hematological disorders such as bleeding disorders.
  • Patients with a history of retinitis pigmentosa, proliferative diabetic retinopathy or non-arteritic anterior ischemic optic neuropathy (NAION).
  • Patients with a history of sickle cell disease, multiple myeloma, leukemia or any other disorders that may cause priapism.
  • Patients on concomitant treatment with nitrates/nitrites(NO) donor, CYP3A4 inhibitors, CYP3A4 inducers, anticoagulants, androgens, antiandrogens or trazodone.
  • Patients with known hypersensitivity to PDE 5 inhibitors like Sildenafil, Vardenafil or Tadalafil.
  • Patient with known diagnosis to AIDS or with a positive HIV result at study screening visit.
  • Patients with any other serious concurrent illness or malignancy.
  • Patients with continuing history of alcohol and / or drug abuse.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Ankara, 06100, Turkey (Türkiye)

Location

Unknown Facility

Ankara, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, Turkey (Türkiye)

Location

Unknown Facility

Izmir, Turkey (Türkiye)

Location

Unknown Facility

Mersin, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

udenafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2011

First Posted

February 28, 2011

Study Start

October 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations

TU(5)