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Effect of Udenafil on Spermatogenesis

Sponsor
Warner Chilcott (Industry)
Overall Status
Completed
CT.gov ID
NCT01230541
Collaborator
(none)
239
Enrollment
23
Locations
2
Arms
14
Duration (Months)
10.4
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects on semen characteristics.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Safety Study in male subjects with no or mild ED (erectile dysfunction)

Study Design

Study Type:
Interventional
Actual Enrollment :
239 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Official Title:
Effect of Udenafil on Spermatogenesis: A Double-blind, Randomized, Placebo-controlled, Parallel-group Study
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo

Drug: Placebo
Daily, oral tablet
Active Comparator: Udenafil

Udenafil daily tablet

Drug: Udenafil
Daily tablet

Outcome Measures

Primary Outcome Measures

  1. Sperm Concentration Reduction greater than or equal to 50% at Week 26 [26 weeks]

    Percentage of Subjects with greater than or equal to 50% decrease from baseline in sperm concentration at 26 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 64 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • No or mild ED (erectile dysfunction) willing & able to provide 2 semen samples without the use of PDE-5 inhibitor or other excluded medication or devices on 2 separate days during screening and at Weeks 12 & 26

  • BMI (body mass index) between 19 and 31 kilogram/meter squared

Exclusion Criteria:

  • New onset coronary artery disease within last 3 months, history of myocardial infarction or cardiac surgical procedure within last 6 months or sudden cardiac arrest

  • Nitrate medications for angina pectoris

  • Used of anti-arrhythmic drug treatment or device

  • Congestive heart failure

  • Uncontrolled diabetes

  • Stroke or transient ischemic attack (TIA) within last 6 months

  • Bleeding disorder or history of GI bleeding within last 12 months

  • Cancer chemotherapy

  • History of alcohol or drug abuse

Contacts and Locations

Locations

Site City State Country Postal Code
1 Warner Chilcott Investigational Site Huntsville Alabama United States 35801
2 Warner Chilcott Investigational Site Anaheim California United States 92801
3 Warner Chilcott Investigational Site San Diego California United States 92103
4 Warner Chilcott Investigational Site San Diego California United States 92120
5 Warner Chilcott Investigational Site Tarzana California United States 91356
6 Warner Chilcott Investigational Site Middlebury Connecticut United States 06762
7 Warner Chilcott Investigational Site Aventura Florida United States 33180
8 Warner Chilcott Investigational Site Clearwater Florida United States 33759
9 Warner Chilcott Investigational Site Doral Florida United States 33166
10 Warner Chilcott Investigational Site Ocala Florida United States 34474
11 Warner Chilcott Investigational Site Pinellas Park Florida United States 33782
12 Warner Chilcott Investigational Site Atlanta Georgia United States 30342
13 Warner Chilcott Investigational Site Shreveport Louisiana United States 71115
14 Warner Chilcott Investigational Site Plainsboro New Jersey United States 08536
15 Warner Chilcott Investigational Site Garden City New York United States 11530
16 Warner Chilcott Investigational Site Great Neck New York United States 11021
17 Warner Chilcott Investigational Site Purchase New York United States 10577
18 Warner Chilcott Investigational Site Williamsville New York United States 14221
19 Warner Chilcott Investigational Site Cincinnati Ohio United States 45212
20 Warner Chilcott Investigational Site San Antonio Texas United States 78229
21 Warner Chilcott Investigational Site Webster Texas United States 77598
22 Warner Chilcott Investigational Site Norfolk Virginia United States 23507
23 Warner Chilcott Investigational Site Spokane Washington United States 99204

Sponsors and Collaborators

  • Warner Chilcott

Investigators

  • Study Director: Herman Ellman, MD, Warner Chilcott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01230541
Other Study ID Numbers:
  • PR-00110
First Posted:
Oct 29, 2010
Last Update Posted:
Nov 30, 2011
Last Verified:
Nov 1, 2011
Keywords provided by Warner Chilcott
Semen characteristics
Erectile Dysfunction
Additional relevant MeSH terms:
Erectile Dysfunction
Udenafil

Study Results

No Results Posted as of Nov 30, 2011