Erectile Dysfunction Clinical Trial
Official title:
A Single Centre, Open-label, Randomised, Single Dose, Six Period, Reference Replicate, Crossover Study to Evaluate the Bioavailability of MED2005
Futura Medical Developments Ltd (FMD) are developing a gel formulation of GTN (MED2005) as a
topical treatment for ED delivered using DermaSys®, a versatile and bespoke technology.
Treatment requires the application of a small quantity of gel (approx 300 mg), containing a
fixed dose of GTN, to the glans of the penis. Pharmacokinetic studies in healthy volunteers
indicate rapid absorption of the drug and low systemic exposure, reducing the risk of adverse
events (such as headache) commonly associated with GTN therapy.
The purpose of this study is to demonstrate similar or lower bioavailability of GTN from
MED2005 (test IMP) with that from Nitrostat (reference IMP).
The study will be conducted in two parts (Part 1 and 2). Part 1 will be conducted in 30
subjects and Part 2 will be conducted in 10 subjects. Part 1 will compose of a pre-study
screen, followed by six treatment periods and a post-study follow-up.
Part 2 will compose of a pre-study screen, followed by two treatment periods and a post-study
follow-up. Subjects can only participate in either Part 1 or 2 of the study (not both).
GTN is a well‐established vasodilatory therapeutic agent with a long, documented history of
use and comprehensive safety profile. In Europe, licensed indications for GTN include the
treatment and prophylaxis of angina pectoris and the relief of pain associated with chronic
anal fissure. Other indications for prescription only parenteral products include use during
cardiac surgery and for emergency reduction of blood pressure.
GTN's vasodilatory action is thought to result from the release of nitric oxide (NO) in
vascular smooth muscle. NO stimulates guanylate cyclase, the enzyme responsible for
production of cGMP, whose action is to lower intracellular calcium resulting in smooth muscle
relaxation and vasodilation.
In the case of erectile dysfunction, GTN works locally by penetrating the glans/penile skin
and directly targeting penile blood vessels. Nitrates appear to have a direct, local effect
on penile haemodynamics. The most likely mechanism for the erectile effect of nitrates
involves nitrate induced dilation of the cavernous and helicine arteries, thereby increasing
blood flow to the lacunar spaces, coupled with nitrate‐induced relaxation of trabecular
smooth muscle.
Nitroglycerin (Nitrostat) is indicated for the acute relief of an attack or acute prophylaxis
of angina pectoris due to coronary artery disease.
The principal pharmacological action of nitroglycerin is relaxation of vascular smooth
muscle. Although venous effects predominate, nitroglycerin produces, in a dose-related
manner, dilation of both arterial and venous beds. Dilation of postcapillary vessels,
including large veins, promotes peripheral pooling of blood, decreases venous return to the
heart, and reduces left ventricular end-diastolic pressure (preload). Nitroglycerin also
produces arteriolar relaxation, thereby reducing peripheral vascular resistance and arterial
pressure (afterload), and dilates large epicardial coronary arteries; however, the extent to
which this latter effect contributes to the relief of exertional angina is unclear.
Nitroglycerin forms free radical nitric oxide (NO) which activates guanylate cyclase,
resulting in an increase of guanosine 3'5' monophosphate (cyclic GMP) in smooth muscle and
other tissues. These events lead to dephosphorylation of myosin light chains, which regulate
the contractile state in smooth muscle, and result in vasodilatation.
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