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

NCT ID: NCT03813992

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1005 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-01-17

Brief 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.

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

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MED2005 0.2%

MED2005 0.2% w/w gel to deliver 0.6 mg dose of GTN applied topically prior to a sexual intercourse attempt

Group Type: ACTIVE_COMPARATOR

MED2005

Intervention Type: DRUG

Topical Product

MED2005 0.4%

MED2005 0.4% w/w gel to deliver 1.2 mg dose of GTN applied topically prior to a sexual intercourse attempt

Group Type: ACTIVE_COMPARATOR

MED2005

Intervention Type: DRUG

Topical Product

MED2005 0.6%

MED2005 0.6% w/w gel to deliver 1.8 mg dose of GTN applied topically prior to a sexual intercourse attempt

Group Type: ACTIVE_COMPARATOR

MED2005

Intervention Type: DRUG

Topical Product

Placebo vehicle

Placebo vehicle applied topically prior to a sexual intercourse attempt

Group Type: PLACEBO_COMPARATOR

MED2005

Intervention Type: DRUG

Topical Product

Interventions

MED2005

Topical Product

Intervention Type: DRUG

Other Intervention Names

Glyceryl Trinitrate

Eligibility Criteria

Inclusion Criteria

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. 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

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. Subjects who are or wish to become pregnant will not be included in the study.

Exclusion Criteria

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; therefore, the PI must consider this carefully and include subjects at their 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 sildenafil citrate, tadalafil, vardenafil and other 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, as the use of GTN in such states could produce severe hypotension or shock

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 (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

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 hepatitis B surface antigen (HBsAG), hepatitis C antibody, and human immunodeficiency virus (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 four 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 received any investigational product during the 90 days prior to dosing for this study

35. Subject or his partner cannot communicate reliably with the PI

36. Subjects with severe premature ejaculation (little or no control of ejaculation at the time of penetration)

1. 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

2. 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.

3. 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

4. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Futura Medical Developments Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim J Holland, MBA

Role: STUDY_DIRECTOR

Clinical Development Director

Locations

UMHAT Burgas EAD

Burgas, , Bulgaria

Multiprofile Hospital for Active Treatment

Pleven, , Bulgaria

University Multiprofile Hospital for Active Treatment

Plovdiv, , Bulgaria

Urology Office Diagnostic-Consultative Center

Varna, , Bulgaria

Medical Center Biomed

Vidin, , Bulgaria

URAN MUDr.Jan Hiblbauer s.r.o

Hradec Králové, , Czechia

ANDROGEOS, spol. s.r.o.

Prague, , Czechia

Urosante s.r.o.

Prague, , Czechia

LTD Gormedi

Gori, , Georgia

LTD Gidmedi

Tbilisi, , Georgia

LTD Multiprofile Clinic Consilium Medulla

Tbilisi, , Georgia

LTDHealth House

Tbilisi, , Georgia

Synexus Magyarorszag Kft

Budapest, , Hungary

Civis Egeszseghaz

Debrecen, , Hungary

Korona Prevent-Med Kft.

Sopron, , Hungary

Aranyklinika

Szeged, , Hungary

Latgales Urology Center

Daugavpils, , Latvia

V. Lietuviesa Private Practice

Riga, , Latvia

Vidzemes Hospital

Valmiera, , Latvia

Indywidualna Specjalistyczna Praktyka Lekarska Dr Adam Sipinski

Katowice, , Poland

PROVITA Specjalistyczna Praktyka Ginekologiczno-Seksuologiczna

Lublin, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska

Szczecin, , Poland

Gabinet Lekarski Ryszard Smolinski

Wroclaw, , Poland

Regional Budgetary Healthcare Institution "Ivanovskaya Regional Clinical Hospital"

Ivanovo, , Russia

CJSC "Nasledniki"

Moscow, , Russia

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, , Russia

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, , Russia

LLC "Bessalar Clinic"

Moscow, , Russia

LLC "Unimed-S"

Moscow, , Russia

State Budgetary Institution "Hospital for War Veterans"

Rostov-on-Don, , Russia

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, , Russia

LLC "Medical center PRIME ROSE"

Saint Petersburg, , Russia

LLC "Sanavita"

Saint Petersburg, , Russia

Llc <<Mart>>

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

Research Center "Eco-Safety"

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

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, , Russia

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, , Russia

SBHI of Leningradskaya region "Vsevolozhskaya Clinical Interdistrict Hospital"

Vsevolozhsk, , Russia

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, , Russia

Urologicka ambulancia

Košice, , Slovakia

Urologicka ambulancia Urobet s.r.o.

Malacky, , Slovakia

Urologicka ambulancia Uroexam s.r.o.

Nitra, , Slovakia

Privatna urologicka ambulancia s.r.o.

Trenčín, , Slovakia

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

Cherkasy, , Ukraine

Regional Clinical Hospital, Polyclinic Department

Ivano-Frankivsk, , Ukraine

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, , Ukraine

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

Kyiv, , Ukraine

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

Kyiv, , Ukraine

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

Odesa, , Ukraine

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

Vinnytsia, , Ukraine

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

Zhytomyr, , Ukraine

Countries

Bulgaria; Czechia; Georgia; Hungary; Latvia; Poland; Russia; Slovakia; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

FM57

Identifier Type: -

Identifier Source: org_study_id