This study investigates a drug intended for the treatment of male patients self-diagnosed with Erectile Dysfunction MedDRA version: 18.0 Level: PT Classification code 10061461 Term: Erectile dysfunction System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Glyceryl Trinitrate (GTN) 0.2% w/w Gel
Product Code: MED2005
Pharmaceutical Form: Gel
INN or Proposed INN: Glyceryl Trinitrate (GTN)
Sponsors
Futura Medical Developments Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Subject is a male aged between 18 and 70 years of age inclusive, at screening. 2.Confirmed self-diagnosis of ED for more than 3 months according to the NIH Consensus Statement (“the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance at least once.”). 3.The 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. 4.Subject answers “yes” to the question regarding the presence of residual erectile function over the past 3 months “At home over the past 3 months, have you experienced at least some growth of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?” 5.Subject has been involved in a continuous heterosexual relationship for at least 6 months prior to screening. 6.Documented written informed consent from both subject and his female partner. 7.Subjects and their partners must agree to use one of the acceptable methods of contraception listed below: •Use acceptable methods of contraception if the male subject's female partner could become pregnant from the time of the first administration of treatment or study medication until 1 month following administration of the last treatment or dose of study medication. The acceptable methods of contraception are as follows: -Occlusive cap (diaphragm or cervical/vault caps). -Surgical sterilisation (vasectomy with documentation of azoospermia). -The female partner uses oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or subdermal implants. -The female partner uses medically prescribed topically-applied transdermal contraceptive patch. -The female partner has undergone documented tubal ligation (female sterilisation). -The female partner has undergone documented placement of an IUD or IUS. 8.Subject and their female partner are capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form prior to participation of any study-related procedures. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 192 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1.Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease. 2.Subject has any history of an unstable medical or psychiatric condition or using any medication that, in the opinion of the PI, is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study. 3.Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or delegate at screening (subjects may be enrolled 7 days after completion of antibiotic therapy with a clinical cure; if a subject develops a urinary tract infection after screening, they may be continued in the study if they receive appropriate antibiotic therapy). 4.Any presence of chronic indwelling urethral catheterization or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function. 5.Any history of operations for Peyronie’s disease. 6.Primary hypoactive sexual desire or any history of hypogonadism 7.Any history of radical prostatectomy. 8.Any history of severe / uncontrolled diabetes. 9.Subjects taking two or more anti-hypertensives for the treatment of blood pressure. 10.Subjects with nursing partners, known pregnant partners or wish to become pregnant during the course of the study. 11.Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, tricyclic antidepressants and methadone) or from the alcohol breath test at screening and on admission (Day -1). 12.Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse. Alcohol abuse is defined as regular weekly intake of more than 14 units if female and 21 units if male (using alcohol tracker http://www.nhs.uk/Tools/Pages/NHSAlcoholtracker.aspx); drug abuse is defined as compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms. 13.Subject has a positive screen for hepatitis B consisting of Hepatitis B surface antigen (HBsAG), hepatitis C antibody, and human immunodeficiency virus (HIV). 14.Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission. 15.Subjects unwilling to cease use of vacuum devices, intracavernosal injecton, Viagra® or other therapy for ED with the exception of erection / tension rings for the entire course of the study. 16.Unwillingness of the subject to agree to make four attempts at sexual intercourse on four separate days during each treatment period. 17.Any history of unresponsiveness to Viagra® treatment due to lack of efficacy with sexual stimulation after multiple attempts of sexual intercourse, or significant side-effects excluding visual disturbances of Viagra®. 18.Less than 4 attempts at sexual intercourse or high IIEF scores (>25) during the run-in-period (excluded prior to entry into period 1). 19.Any known hypersensitivity to any component of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess how well a new medication known as MED2005 works (i.e.causes an erection) when applied to the penis of male volunteers self-diagnosed with Erectile Dysfunction (ED) using scores from a validated questionnaire known as IIEF (International Index for Erectile Function).; Secondary Objective: To assess how well a new medication known as MED2005 works (i.e. causes an erection) when applied to the penis of male volunteers self-diagnosed with Erectile Dysfunction (ED) using scores from validated questionnaire known as SEP (Sexual Encounter Profile) and GAQ (Global Assessment Questionnaire), including subjective measures of the time of onset of action, time to peak effect and offset of action. To assess how safe and acceptable MED2005 is in ED sufferers and their partners including the subject’s preference. ; Primary end point(s): Efficacy The efficacy of MED2005 will be assessed using the experience of male volunteers and their female partners based on the validated questionnaires [International Index for Erectile Function (IIEF) questionnaire (male volunteers only), the Sexual Encounter Profile (SEP) questionnaire, Global Assessment Questionnaire (GAQ)], Onset/Offset of Action questions, and an overall volunteer preference question, by comparing the active drug to placebo arm within each subject. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety analysis Safety will be evaluated using standard clinical laboratory safety tests (haematology, biochemistry, coagulation and urinalysis), vital signs (temperature, blood pressure [BP] and heart rate [HR]), physical examinations, 12 lead ECG, and AE monitoring before and after each treatment period. | — |
Countries
Poland, United Kingdom
Contacts
Public ContactCEO
Richmond Pharmacology Ltd.
Outcome results
None listed