Clinical trial NCT04984993: Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
Official title: A Multi-centre, Randomised, Open-label, Home Use, Parallel Group, Clinical Investigation of Topically-applied MED3000 Gel and Oral Tadalafil (5 mg) Tablets for the Treatment of Erectile Dysfunction (ED) Over a 24 Week Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: Futura Medical Developments Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-02
Enrollment: 116
Sex: MALE
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets after a 4 -6 week screening period
Primary purpose: TREATMENT

Brief summary: An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected to participate for up to 30 weeks. Eligible patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.


Eligibility criteria: Inclusion Criteria:

* Male heterosexual patients aged 22-70 years.
* Confirmed clinical diagnosis of mild, moderate or severe ED for more than 3 months.
* Involved in a continuous heterosexual relationship with their partner for at least 6 months.

Exclusion Criteria:

* Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease.
* History of unstable medical or psychiatric condition or using any medication that, in the opinion of the Principal Investigator, is likely to affect the patient's ability to complete the investigation or precludes the patient's participation in the investigation.

Primary outcomes:
measure: Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire, in Patients Randomised to MED3000, at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000.
timeFrame: 24 weeks
measure: Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Dupnitsa
country: Bulgaria
facility: Medical Center "Asklepii"OOD
city: Plovdiv
country: Bulgaria
facility: ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry"
city: Plovdiv
country: Bulgaria
facility: UMHAT Plovdiv AD
city: Silistra
country: Bulgaria
facility: MHAT "Silistra"AD
city: Sofia
country: Bulgaria
facility: Medical Center "INTERMEDICA"ООD
city: Batumi
country: Georgia
facility: LTD Health
city: Kutaisi
country: Georgia
facility: Jsc "Evex Clinics"
city: Rustavi
country: Georgia
facility: Rustavi N2 Medical Diagnostic Center
city: Tbilisi
country: Georgia
facility: Clinic "GIDMEDI"
city: Tbilisi
country: Georgia
facility: JSC "Evex clinics"
city: Tbilisi
country: Georgia
facility: Raymann LLC
city: Katowice
country: Poland
facility: The Mikolowska Medical Center
city: Katowice
country: Poland
facility: Provita Sp. z o.o.
city: Kraków
country: Poland
facility: Medistica Osteomed
city: Lublin
country: Poland
facility: PROVITA Specialised Gynecology and Sexology Practice
city: Warsaw
country: Poland
facility: Sexology and Pathology of Intercourse Clinic
city: Wrocław
country: Poland
facility: Ryszard Smoliński's Medical Cabinet
Study officials:
affiliation: Johns Hopkins University
name: Arthur Burnett, MD
role: PRINCIPAL_INVESTIGATOR
References: