A Phase II Clinical Study to Compare the Efficacy and Safety of Three Doses of Topical Glyceryl Trinitrate (GTN) to Placebo in Subjects with Mild and/or Moderate Erectile Dysfunction (ED)

Futura Medical Developments (FMD)0 sites272 target enrollmentJanuary 12, 2007

ConditionsMild and/or moderate erectile dysfunction (ED)MedDRA version: 8.1Level: LLTClassification code 10061461Term: Erectile dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mild and/or moderate erectile dysfunction (ED)
Sponsor: Futura Medical Developments (FMD)
Enrollment: 272
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 12, 2007

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Futura Medical Developments (FMD)

Eligibility Criteria

Inclusion Criteria

•A subject will be eligible for inclusion in this study only if all of the following criteria apply:
•1\.Aged between 18 and 65 years of age.
•2\.Males with mild and/or moderate ED for more than 6 months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
•3\.IIEF\-EF score in the range of 11 to 25 inclusive, denoting mild and/or moderate ED at screening.
•4\.The subject must make at least four attempts at sexual intercourse (according to the question in the screening phase diary: Was sexual activity initiated with the intention of intercourse?”) on four separate days during the 4 weeks of the treatment\-free run\-in period.
•5\.50% or more of the attempts during the 4 week run\-in period must be unsuccessful, according to the following questions from the screening phase diary \[at least one question should be answered No]: Were you able to achieve at least some erection (some enlargement of the penis)?”, Were you able to insert your penis into your partner’s vagina?” and Did your erection last long enough for you to have successful intercourse?.
•6\.Stable monogamous heterosexual relationship for more than 6 months prior to screening.
•7\.Reproduction and Contraception (at least one of the following criteria must apply):
•a)Sterile male subjects documented by bilateral vasectomy, bilateral orchiectomy, or azoospermia prior to the subject’s entry into the study, OR
•b)Female partners of study subjects that are of child bearing potential that are practicing a satisfactory method of contraception for at least 3 months prior to screening:

Exclusion Criteria

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•Previous or Current Medical Conditions
•1\.Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study.
•2\.Presence of penile anatomical abnormalities (e.g., phimosis, penile fibrosis or Peyronie’s disease) that, in the opinion of the Investigator, would significantly impair sexual performance.
•3\.Primary hypoactive sexual desire.
•4\.Spinal cord injury.
•5\.History of any pelvic surgery (prostatectomy, colon surgery).
•6\.A history of priapism.
•7\.Clinically significant chronic haematological disease which may lead to priapism such as sickle cell anaemia, multiple myeloma or leukaemia.
•8\.Any underlying cardiovascular condition including unstable angina pectoris that would preclude sexual activity.