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Erectile DysfunctionPhase 3NCT03813992

Clinical Trial Using Topically Applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction

A Phase 3 study testing MED2005 in people with Erectile Dysfunction, run by Futura Medical Developments Ltd. at 53 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To demonstrate the efficacy of various doses of MED2005 versus placebo in male patients with clinically diagnosed erectile dysfunction, and to evaluate the long-term efficacy and safety (12 months) of MED2005. Read more about this study

Who is it for?
Ages 18 to 70 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
MED2005
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,005 participants
Where
53 sitesin 9 countries
Study dates
1 Nov 2018to 17 Jan 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is a male aged between 18 and 70 years inclusive, at screening
  • 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')
  • 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?'
  • Subject has been involved in a continuous heterosexual relationship for at least 6 months prior to screening
  • Documented written informed consent from both subject and his female partner
  • 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. Subjects who are or wish to become pregnant will not be included in the study.
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  • 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
  • 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):
  • Subject and his female partner complete the double-blind phase
  • Subject and his female partner were compliant to study procedures during the double blind phase
  • Documented written informed consent from both subject and his female partner
  • 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. Subjects who are or wish to become pregnant will not be included in the study.

Who cannot join

  • 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
  • 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; therefore, the PI must consider this carefully and include subjects at their discretion
  • Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or their delegate at screening or during the study
  • Any presence of chronic indwelling urethral catheterisation or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair EF
  • Any history of operations for Peyronie's disease
  • Primary hypoactive sexual desire or any history of hypogonadism
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  • Any history of radical prostatectomy
  • Any history of severe/uncontrolled diabetes
  • Subjects taking two or more anti hypertensives for the treatment of BP
  • Hypersensitivity to GTN or to any of the excipients, or idiosyncratic reactions to other organic nitrates
  • Concomitant treatment with sildenafil citrate, tadalafil, vardenafil and other PDE 5 inhibitors
  • Subjects taking Alpha blockers
  • Subjects receiving testosterone pellets
  • Any penile surgery except circumcision
  • Any treatment with acetyl cysteine within 6 months
  • Any treatment with dihydroergotamine within 6 months
  • Postural hypotension, hypotension or uncorrected hypovolaemia, as the use of GTN in such states could produce severe hypotension or shock
  • Increased intracranial pressure (e.g. head trauma or cerebral haemorrhage) or inadequate cerebral circulation
  • Any history of migraine or recurrent headache
  • Aortic or mitral stenosis
  • Hypertrophic obstructive cardiomyopathy
  • Constrictive pericarditis or pericardial tamponade
  • Closed-angle glaucoma
  • Subjects with nursing partners, known pregnant partners or with partners who wish to become pregnant during the course of the study
  • 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 (for clarification, any positive result from the urine drug screen or alcohol breath tests at screening will mean the subject will be excluded from the study). In the instance that a subject is using medication which may give a positive result, exclusion will be at the PI's discretion
  • Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse.
  • Subject has a positive screen for hepatitis B, consisting of hepatitis B surface antigen (HBsAG), hepatitis C antibody, and human immunodeficiency virus (HIV)
  • 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
  • Subjects unwilling to cease use of vacuum devices, intracavernosal injections, PDE-5s or other therapy for ED for the entire course of the study
  • Unwillingness of the subject or their partner to agree to make the required attempts at sexual intercourse during treatment period
  • Any history of unresponsiveness to PDE 5 treatment or significant side effects, excluding visual disturbances, with PDE 5s
  • Fewer than four attempts at sexual intercourse during the screening period
  • Subjects or their partners who are illiterate or are unable to understand the language in which the questionnaires are available
  • Subject has received any investigational product during the 90 days prior to dosing for this study
  • Subject or his partner cannot communicate reliably with the PI
  • Subjects with severe premature ejaculation (little or no control of ejaculation at the time of penetration)
  • Subjects are prohibited from participating in the open-label extension phase of the study if they meet any of the following exclusion criteria at the follow-up visit of the double-blind phase (Visit 6):
  • Subsequent to recruitment into the double-blind phase of the study, the development of 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 continue in the open-label extension phase of the study
  • Subject using any medication that, in the opinion of the PI, is likely to affect the subject's ability to complete or participate in the open-label phase of the study.
  • NB The concomitant medications listed as exclusion criteria for the study apply to the open-label extension phase. Certain concomitant medications; e.g. other vasodilators, calcium channel blockers, 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; therefore, the PI must consider this carefully and include subjects at their discretion
  • Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or their delegate at the start of the open-label extension phase
  • Subsequent to recruitment into the double-blind phase of the study, the development of postural hypotension, hypotension or uncorrected hypovolaemia, increased intracranial pressure or inadequate cerebral circulation, any clinically significant vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at Visit 6 prior to recruitment to the open-label phase

Trial locations and contacts

53 sites in 9 countries.

53 sites in 9 countries

Russia18 sites

  • Regional Budgetary Healthcare Institution "Ivanovskaya Regional Clinical Hospital"

    Ivanovo

  • CJSC "Nasledniki"

    Moscow

  • Federal State Budgetary Institution "National Medical Research Center of Obstetrics, Gynecology and Perinatology n.a. acad. V.I. Kulakov" of the Ministry of Healthcare of the Russian Federation

    Moscow

  • FSBEI HE "Russian National Research Medical University n.a. N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation, Russian Gerontological Scientific and Research Center

    Moscow

  • LLC "Bessalar Clinic"

    Moscow

  • LLC "Unimed-S"

    Moscow

  • State Budgetary Institution "Hospital for War Veterans"

    Rostov-on-Don

  • Federal State Budgetary Educational Institution of Higher Education "North-Western State Medical University n.a. I.I. Mechnikov" of the Ministry of Healthcare of the Russian Federation

    Saint Petersburg

  • LLC "Medical center PRIME ROSE"

    Saint Petersburg

  • LLC "Sanavita"

    Saint Petersburg

  • Llc <<Mart>>

    Saint Petersburg

  • Medicosanitary Department No.70, branch of Saint-Petersburg State Unitary Institution of road passenger transport

    Saint Petersburg

  • Research Center "Eco-Safety"

    Saint Petersburg

  • Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 4"

    Saint Petersburg

  • Clinical Hospital n.a. S.R. Mirotvortseva of the Federal State Budgetary Educational Institution of Higher Education "Saratovskiy State Medical University n.a. V.I. Razumovskiy" of the Ministry of Healthcare of the Russian Federation

    Saratov

  • Federal State Budgetary Educational Institution of Higher Education " Voronezhskiy State Medical University n.a. N.N. Burdenko" of the Ministry of Healthcare of the Russian Federation on the clinical base of Budgetary Healthcare Institution of Voronezhsk

    Voronezh

  • SBHI of Leningradskaya region "Vsevolozhskaya Clinical Interdistrict Hospital"

    Vsevolozhsk

  • FSBEI HPE "Yaroslavskiy State Medical University" of The Ministry of Healthcare of the Russian Federation with clinical base in State Autonomous Institution of Yaroslavskaya region "Clinical Hospital No.9"

    Yaroslavl

Other trials in Russia

Ukraine8 sites

  • Municipal Establishment "Cherkasy Regional Hospital of Cherkasy Regional Council", Urology department

    Cherkasy

  • Regional Clinical Hospital, Polyclinic Department

    Ivano-Frankivsk

  • Kyiv Clinical Hospital on Railway Transport #1 of the branch "Health Center" of the public joint stock company "Ukrainian Railway", consulting and diagnostic center

    Kyiv

  • State Institution "Institute of urology of the National Academy of Medical Science of Ukraine", policlinic department

    Kyiv

  • State Institution "Institute of urology of the National Academy of Medical Sciences of Ukraine", Department of Sexual Pathology and Andrology

    Kyiv

  • "Ambulatory of General Practice-Family Medicine",LLC, Medical Center

    Odesa

  • Private Small-Scale Enterprise Medical Centre "Pulse" , Therapeutic Department

    Vinnytsia

  • Municipal Institution Central City Hospital №1 of Zhytomyr, consulting and medical department "Research center"

    Zhytomyr

Other trials in Ukraine

Bulgaria5 sites

  • UMHAT Burgas EAD

    Burgas

  • Multiprofile Hospital for Active Treatment

    Pleven

  • University Multiprofile Hospital for Active Treatment

    Plovdiv

  • Urology Office Diagnostic-Consultative Center

    Varna

  • Medical Center Biomed

    Vidin

Other trials in Bulgaria

Georgia4 sites

  • LTD Gormedi

    Gori

  • LTD Gidmedi

    Tbilisi

  • LTD Multiprofile Clinic Consilium Medulla

    Tbilisi

  • LTDHealth House

    Tbilisi

Other trials in Georgia

Hungary4 sites

  • Synexus Magyarorszag Kft

    Budapest

  • Civis Egeszseghaz

    Debrecen

  • Korona Prevent-Med Kft.

    Sopron

  • Aranyklinika

    Szeged

Other trials in Hungary

Poland4 sites

  • Indywidualna Specjalistyczna Praktyka Lekarska Dr Adam Sipinski

    Katowice

  • PROVITA Specjalistyczna Praktyka Ginekologiczno-Seksuologiczna

    Lublin

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Szczecin

  • Gabinet Lekarski Ryszard Smolinski

    Wroclaw

Other trials in Poland

Slovakia4 sites

  • Urologicka ambulancia

    Košice

  • Urologicka ambulancia Urobet s.r.o.

    Malacky

  • Urologicka ambulancia Uroexam s.r.o.

    Nitra

  • Privatna urologicka ambulancia s.r.o.

    Trenčín

Other trials in Slovakia

Czechia3 sites

  • URAN MUDr.Jan Hiblbauer s.r.o

    Hradec Králové

  • ANDROGEOS, spol. s.r.o.

    Prague

  • Urosante s.r.o.

    Prague

Other trials in Czechia

Latvia3 sites

  • Latgales Urology Center

    Daugavpils

  • V. Lietuviesa Private Practice

    Riga

  • Vidzemes Hospital

    Valmiera

Other trials in Latvia

About this study

Official title: A Phase III, Dose Ranging, Multi-centre, Randomised, Double Blind, Placebo Controlled, Home Use, Parallel Group Clinical Trial of Topically-applied Glyceryl Trinitrate for the Treatment of Erectile Dysfunction, With an Open Label Extension

To demonstrate the efficacy of various doses of MED2005 versus placebo in male patients with clinically diagnosed erectile dysfunction, and to evaluate the long-term efficacy and safety (12 months) of MED2005.

Read the detailed description

A phase III, dose-ranging, multi-centre, randomised, double-blind, placebo controlled , home-use, parallel group clinical trial of topically applied glyceryl trinitrate for the treatment of erectile dysfunction with an open label extension

Being tested
MED2005
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MED2005Drug

    Also called Glyceryl Trinitrate

    Topical Product

Study groups in NCT03813992
Study groupRoleWhat they receive
MED2005 0.2%Active comparatorMED2005 0.2% w/w gel to deliver 0.6 mg dose of GTN applied topically prior to a sexual intercourse attempt
Receives: Drug: MED2005
MED2005 0.4%Active comparatorMED2005 0.4% w/w gel to deliver 1.2 mg dose of GTN applied topically prior to a sexual intercourse attempt
Receives: Drug: MED2005
MED2005 0.6%Active comparatorMED2005 0.6% w/w gel to deliver 1.8 mg dose of GTN applied topically prior to a sexual intercourse attempt
Receives: Drug: MED2005
Placebo vehiclePlacebo comparatorPlacebo vehicle applied topically prior to a sexual intercourse attempt
Receives: Drug: MED2005

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. International Index for Erectile Function (IIEF) Questionnaire

    A questionnaire containing 15 questions divided into 5 domains; erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.

    Measured: Up to Week 64 of the study

  2. Sexual Encounter Profile (SEP) Questionnaire (Question 2)

    A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.

    Measured: Up to Week 64 of the study

  3. Sexual Encounter Profile (SEP) Questionnaire (Question 3)

    A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.

    Measured: Up to Week 64 of the study

Secondary outcomes (9)

  1. Self-Esteem and Relationship (SEAR) Questionnaire

    A questionnaire to support the validity and reliability for measuring sexual relationship satisfaction, satisfaction, confidence, and self-esteem in men with erectile dysfunction.

    Measured: Up to Week 12 of the study.

  2. Global Assessment Questionnaire (GAQ)

    A questionnaire that allows patients and their partners to rate (yes or no) an improvement in erectile function.

    Measured: Up to Week 12 of the study.

  3. International Index for Erectile Function (IIEF) Questionnaire (additional domains)

    A questionnaire containing 15 questions divided into 5 domains; erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.

    Measured: Up to Week 64 weeks of the study.

  4. Sexual Encounter Profile (SEP) Questionnaire (Questions 1, 4 & 5)

    A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.

    Measured: Up to Week 64 of the study.

  5. Sexual Encounter Profile (SEP) Questionnaire

    A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.

    Measured: Up to Week 64 of the study

  6. Patient Global Impression of Severity (PGI-S)

    A one item questionnaire to rate the severity of a patient's erectile dysfunction. This is a single-state 5-point categorical scale.

    Measured: Up to Week 12 of the study.

  7. Patient Global Impression of Change (PGI-C)

    A one item questionnaire to rate a perceived change in a patient's erectile function. This is a transitional 7-point categorical scale.

    Measured: Up to Week 12 of the study

  8. Onset and duration of action (erection) and erection hardness

    A questionnaire asking both the patient and the patient's partner about the onset and duration of action of the patient's erection.

    Measured: Up to Week 12 of the study

  9. Usage and application

    A questionnaire has 5 items to assess the usage and application of the investigation product.

    Measured: Up to Week 12 of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2019
  2. Study start1 Nov 2018
  3. Primary completion21 Jul 2019
  4. Study completion17 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,005 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03813992
Sponsor's protocol ID
FM57
Status last verified
Feb 2022
First submitted
15 Jan 2019
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MED2005 in people with Erectile Dysfunction, run by Futura Medical Developments Ltd. at 53 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Russia, Ukraine, Bulgaria, Georgia, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Index for Erectile Function (IIEF) Questionnaire (time frame: Up to Week 64 of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03813992.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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