To see how the medication MED2005 works (i.e. causes an erection) compared to placebo when applied to the penis by male volunteers who normally are unable to obtain an erectio
- Conditions
- Erectile dysfunctionMedDRA version: 20.0Level: PTClassification code 10061461Term: Erectile dysfunctionSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 20.0Level: LLTClassification code 10015116Term: Erectile disturbanceSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 20.0Level: LLTClassification code 10025503Term: Male erectile disorderSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 20.0Level: LLTClassification code 10052003Term: Erectile dysfunction NOSSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2017-000960-14-SK
- Lead Sponsor
- Futura Medical Developments Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1000
1.Subject is a male aged between 18 and 70 years inclusive, at screening
2.Confirmed clinical 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.Subject answers ‘yes’ to the question regarding the presence of residual EF 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?’
4.Subject has been involved in a continuous heterosexual relationship for at least 6 months prior to screening
5.Documented written informed consent from both subject and his female partner
6.If the male subject's female partner is of childbearing potential from the time of first sexual intercourse attempt during the screening period until the last administration of study treatment, then the couple must have been using a medically acceptable form of contraception for at least 3 months prior to entering the study, and agree to continue such use for at least 1 month after the last study drug administration
Acceptable methods of contraception are listed below; it should be noted that condoms, femidoms, diaphragms, caps or hormone rings are not permitted as a form of contraception in this study:
?Surgical sterilisation of the male partner (vasectomy with documentation of azoospermia if possible)
?The female partner has undergone documented tubal ligation (female sterilisation)
?The female partner uses combined hormone injectables
?The female partner uses medically prescribed hormonal implants
?The female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS)
?The female partner uses combined oral contraceptives
?The female partner uses progesterone only contraceptives
?The female partner uses combined hormonal patches
Other than for male/female sterilisation, if any of these above listed methods are being used then their effectiveness must be determined by the PI or their delegate, taking into consideration the compliance and tolerance of the female partner with this method of contraception.
Subjects who are or wish to become pregnant will not be included in the study.
7.Subject and his female partner are capable of understanding and complying with the requirements of the protocol and must have signed the ICF prior to participation in any study related procedures
8.Low IIEF-EF scores (= 25) during the screening period
To continue in the open-label extension phase of the study, subjects must meet the following inclusion criteria at the follow-up visit of the double-blind phase (Visit 6):
1.Subject and his female partner complete the double-blind phase
2.Subject and his female partner were compliant to study procedures during the double blind phase
3.Documented written informed consent from both subject and his female partner
4.If the male subject's female partner is of childbearing potential from the time of first sexual intercourse attempt during the screening period until the last administration of study treatment, then the couple must have been using a medically acceptable form of contraception for at least 3 months prior to entering the study, and agree to continue such use for at least 1 month after the last study drug administration
Acceptable methods of contraception ar
1.Any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease which, in the opinion of the PI, renders the subject unfit to take part in the study
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
Certain concomitant medications; e.g. other vasodilators, calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors, beta blockers, diuretics, anti hypertensives, tricyclic anti depressants and major tranquillisers, as well as the consumption of alcohol, may potentiate the BP lowering effects of MED2005; at PI's discretion
3.Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or their delegate at screening or during the study
4.Any presence of chronic indwelling urethral catheterisation or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair EF
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 BP
10.Hypersensitivity to GTN or to any of the excipients, or idiosyncratic reactions to other organic nitrates
11.Concomitant treatment with PDE 5 inhibitors
12.Subjects taking Alpha blockers
13.Subjects receiving testosterone pellets
14.Any penile surgery except circumcision
15.Any treatment with acetyl cysteine within 6 months
16.Any treatment with dihydroergotamine within 6 months
17.Postural hypotension, hypotension or uncorrected hypovolaemia
18.Increased intracranial pressure (e.g. head trauma or cerebral haemorrhage) or inadequate cerebral circulation
19.Any history of migraine or recurrent headache
20.Aortic or mitral stenosis
21.Hypertrophic obstructive cardiomyopathy
22.Constrictive pericarditis or pericardial tamponade
23.Closed-angle glaucoma
24.Subjects with nursing partners, known pregnant partners or with partners who wish to become pregnant during the course of the study
25.Confirmed positive results from urine drug screen or from the alcohol breath test at screening
26.Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse.
27.Subject has a positive screen for hepatitis B, consisting of HBsAG, hepatitis C antibody, and HIV
28.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
29.Subjects unwilling to cease use of vacuum devices, intracavernosal injections, PDE-5s or other therapy for ED for the entire course of the study
30.Unwillingness of the subject or their partner to agree to make the required attempts at sexual intercourse during treatment period
31.Any history of unresponsiveness to PDE 5 treatment or significant side effects, excluding visual disturbances, with PDE 5s
32.Fewer than 4 attempts at sexual intercourse during the screening period
33.Subjects or their partners who are illiterate or are unable to understand the language in which the questionnaires are available
34.Subject has rece
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method