Erectile Dysfunction Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled, Home Use, Cross-over Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)
This study is designed to evaluate the efficacy and safety of MED2005, a topically applied glyceryl trinitrate (GTN) gel administered to the penis of male subjects self-diagnosed with erectile dysfunction (ED) immediately before sexual intercourse.
This randomised, double-blind, placebo-controlled cross-over study is designed to evaluate
the efficacy and safety of MED2005, a topically applied glyceryl trinitrate (GTN) gel
administered to the penis of male subjects immediately before sexual intercourse. Subjects
will be male aged between 18 and 70 years of age self-diagnosed with ED. Treatment requires
the topical application of a pea sized volume (approximately 300 mg) of a 0.2% (w/w) gel to
deliver a dose of 0.6 mg GTN to the glans of the penis. A total of 192 eligible subjects are
planned to be enrolled into the study. Subjects will be screened for eligibility during the
screening period (Day -45 to Day -2), provide a history of their ED treatments and those
deemed eligible and who have a female consenting partner will participate in a run-in-period
and two treatment periods (treatment period 1 and 2). The International Index for Erectile
Function (IIEF) question 1 -5 and 15 will be used to determine pre-screening eligibility for
the subject online. A score of 25 or less will be acceptable for inclusion to the
run-in-period. Screening (visit 1) will be conducted over 1 day or may be divided into more
than 1 day if wash-out of prior medications is needed. The screening period is applicable for
visit 1 Informed consent will be signed by both partners before a couple can be admitted to
the study. There will also be a subject and partner training requirement to ensure that the
product is applied in an appropriate manner. After refraining from using other ED treatments
for at least a period of a week, in the run-in-period (visit 2), subjects and their female
partners will make at least 4 intercourse attempts (with a minimum of 1 attempt per week)
during a 4 week (± 1 week) period. The subjects and their partners will be asked to complete
questionnaires online to record their experiences after each sexual intercourse attempt and
at the end of the run-in period. Subjects who cannot comply with the minimum number of sexual
attempts verified by completed Sexual Event Profile (SEP) or exceed 25 on the IIEF question 1
-5 and 15 will be excluded from the study. Scores generated from the run-in period will be
used as an established baseline in the planned analyses. The run-in period will be completed
prior to randomisation and dosing.
In treatment period 1 (visit 3 and visit 4), subjects will be allocated to receive either
placebo or MED2005 (0.6 mg GTN) according to a pre-defined randomisation schedule. After
refraining from using other ED treatments for at least a period of a week, subjects and their
female partner will be trained in the application of the test article and asked to apply the
test article immediately prior to sexual intercourse, and to make at least 4 intercourse
attempts during a 4 week (± 1 week) period. The subjects and their partners will be asked to
complete questionnaires online to record their experiences after each sexual intercourse
attempt, and again at the end of each treatment period. Subjects will be asked to return to
the Clinical Pharmacology Unit (CPU) after 4 weeks' (± 1 week) to return used and unused test
article from the first treatment period, to enable the clinical staff to check compliance and
to assess their health status, including assessment of any Adverse Event (AE). At the end of
treatment period 1 (visit 4), tubes will be weighed to ensure subject compliance.
Following a 1 week treatment-free cross-over period, the subjects will enter into treatment
period 2.
In treatment period 2 (visit 5 and visit 6), subjects will be issued with the alternative
test article, either placebo or MED2005 (0.6 mg GTN) according to the pre-defined
randomisation code. Training on the application of the test article will be reinforced /
repeated and the subject or their female partner will be asked to apply the test article
immediately prior to sexual intercourse on at least 4 separate occasions during a 4-week
period. After each intercourse attempt the subjects and their partners will be asked to
complete questionnaires online to record their experiences after each sexual intercourse
attempt, and again at the end of each treatment period.. Subjects will be asked to return to
the CPU after 4 weeks' (± 1 week) time to return used and unused test article from the second
treatment period, to enable the clinical staff to check compliance and to assess their health
status, including assessment of any AEs. At the end of treatment period 2 (visit 6), tubes
will be weighed to ensure subject compliance.
Subjects and their female partners will be followed up at 7 day's ± 2 days (visit 7) after
the outpatient visit on week 4 of treatment period 2, as necessary, to follow up any on-going
AEs.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05366504 -
LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment
|
Phase 2/Phase 3 | |
Recruiting |
NCT02745808 -
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Recruiting |
NCT02573805 -
the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
|
N/A | |
Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
Withdrawn |
NCT02579148 -
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
Recruiting |
NCT02225548 -
Sagene 2014 - Parkinson's Disease and Erectile Dysfunction
|
Phase 4 | |
Completed |
NCT02587988 -
Trial to Evaluate the Efficacy and Safety of HCP1302
|
Phase 3 | |
Completed |
NCT01937871 -
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
|
Phase 3 | |
Completed |
NCT02945462 -
Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)
|
Phase 1 | |
Completed |
NCT01698684 -
Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction
|
Phase 4 | |
Not yet recruiting |
NCT01321489 -
A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies
|
Phase 3 | |
Completed |
NCT01230541 -
Effect of Udenafil on Spermatogenesis
|
Phase 1 | |
Terminated |
NCT01262833 -
Pudendal Assessment in Erectile Dysfunction
|
N/A | |
Completed |
NCT02226237 -
Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy
|
N/A | |
Completed |
NCT01037244 -
Treatment of Erectile Dysfunction I
|
Phase 3 | |
Completed |
NCT01037218 -
Treatment of Erectile Dysfunction II
|
Phase 3 | |
Recruiting |
NCT00313898 -
Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males
|
Phase 4 | |
Completed |
NCT00667979 -
Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
|
Phase 4 | |
Completed |
NCT00663728 -
Assessment of Duration of Erection With Vardenafil 10 mg
|
Phase 4 | |
Completed |
NCT00421083 -
Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury
|
Phase 3 |