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

NCT03813992 | Completed Phase 3

• 1 other identifier: FM57
• Study Type: interventional
• Target: 1,005
• Locations: 9 countries
• Sites: 53

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to Week 64 of the study

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

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

  Up to Week 64 of the study

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

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

  Up to Week 64 of the study

Secondary Outcomes (9)

• Self-Esteem and Relationship (SEAR) Questionnaire

  Up to Week 12 of the study.

• Global Assessment Questionnaire (GAQ)

  Up to Week 12 of the study.

• International Index for Erectile Function (IIEF) Questionnaire (additional domains)

  Up to Week 64 weeks of the study.

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

  Up to Week 64 of the study.

• Sexual Encounter Profile (SEP) Questionnaire

  Up to Week 64 of the study

Study Arms (4)

MED2005 0.2%

ACTIVE COMPARATOR

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

Drug: MED2005

MED2005 0.4%

ACTIVE COMPARATOR

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

Drug: MED2005

MED2005 0.6%

ACTIVE COMPARATOR

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

Drug: MED2005

Placebo vehicle

PLACEBO COMPARATOR

Placebo vehicle applied topically prior to a sexual intercourse attempt

Drug: MED2005

Interventions

MED2005 DRUG

Topical Product

Also known as: Glyceryl Trinitrate

MED2005 0.2%; MED2005 0.4%; MED2005 0.6%; Placebo vehicle

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Male patients must have been in a heterosexual relationship with a female partner for a minimum of 6 months
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Futura Medical Developments Ltd.: lead

Study Sites (53)

UMHAT Burgas EAD

Burgas, Bulgaria

Location

Multiprofile Hospital for Active Treatment

Pleven, Bulgaria

Location

University Multiprofile Hospital for Active Treatment

Plovdiv, Bulgaria

Location

Urology Office Diagnostic-Consultative Center

Varna, Bulgaria

Location

Medical Center Biomed

Vidin, Bulgaria

Location

URAN MUDr.Jan Hiblbauer s.r.o

Hradec Králové, Czechia

Location

ANDROGEOS, spol. s.r.o.

Prague, Czechia

Location

Urosante s.r.o.

Prague, Czechia

Location

LTD Gormedi

Gori, Georgia

Location

LTD Gidmedi

Tbilisi, Georgia

Location

LTD Multiprofile Clinic Consilium Medulla

Tbilisi, Georgia

Location

LTDHealth House

Tbilisi, Georgia

Location

Synexus Magyarorszag Kft

Budapest, Hungary

Location

Civis Egeszseghaz

Debrecen, Hungary

Location

Korona Prevent-Med Kft.

Sopron, Hungary

Location

Aranyklinika

Szeged, Hungary

Location

Latgales Urology Center

Daugavpils, Latvia

Location

V. Lietuviesa Private Practice

Riga, Latvia

Location

Vidzemes Hospital

Valmiera, Latvia

Location

Indywidualna Specjalistyczna Praktyka Lekarska Dr Adam Sipinski

Katowice, Poland

Location

PROVITA Specjalistyczna Praktyka Ginekologiczno-Seksuologiczna

Lublin, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska

Szczecin, Poland

Location

Gabinet Lekarski Ryszard Smolinski

Wroclaw, Poland

Location

Regional Budgetary Healthcare Institution "Ivanovskaya Regional Clinical Hospital"

Ivanovo, Russia

Location

CJSC "Nasledniki"

Moscow, Russia

Location

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

Location

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

Location

LLC "Bessalar Clinic"

Moscow, Russia

Location

LLC "Unimed-S"

Moscow, Russia

Location

State Budgetary Institution "Hospital for War Veterans"

Rostov-on-Don, Russia

Location

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

Location

LLC "Medical center PRIME ROSE"

Saint Petersburg, Russia

Location

LLC "Sanavita"

Saint Petersburg, Russia

Location

Llc <<Mart>>

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Research Center "Eco-Safety"

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

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

Location

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

Location

SBHI of Leningradskaya region "Vsevolozhskaya Clinical Interdistrict Hospital"

Vsevolozhsk, Russia

Location

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

Location

Urologicka ambulancia

Košice, Slovakia

Location

Urologicka ambulancia Urobet s.r.o.

Malacky, Slovakia

Location

Urologicka ambulancia Uroexam s.r.o.

Nitra, Slovakia

Location

Privatna urologicka ambulancia s.r.o.

Trenčín, Slovakia

Location

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

Cherkasy, Ukraine

Location

Regional Clinical Hospital, Polyclinic Department

Ivano-Frankivsk, Ukraine

Location

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

Location

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

Kyiv, Ukraine

Location

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

Kyiv, Ukraine

Location

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

Odesa, Ukraine

Location

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

Vinnytsia, Ukraine

Location

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

Zhytomyr, Ukraine

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Tim J Holland, MBA

  Clinical Development Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 23, 2019
• Study Start: November 1, 2018
• Primary Completion: July 21, 2019
• Study Completion: January 17, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4); LA (3); CZ (3); GE (4); SL (4); RU (18); HU (4); UA (8); BU (5)