Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
NCT ID: NCT04984993
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
116 participants
INTERVENTIONAL
2021-09-14
2022-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MED3000
MED3000 gel formulation topically applied to the glans penis
MED3000 (Male)
Gel formulation
MED3000 (Female)
Gel formulation
Tadalafil
Tadalafil (5 mg) tablets to be taken orally
Tadalafil 5mg (Male)
Tablets
Tadalafil 5mg (Female)
Tablets
Interventions
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MED3000 (Male)
Gel formulation
Tadalafil 5mg (Male)
Tablets
MED3000 (Female)
Gel formulation
Tadalafil 5mg (Female)
Tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
22 Years
70 Years
MALE
No
Sponsors
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Futura Medical Developments Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Arthur Burnett, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Medical Center "Asklepii"OOD
Dupnitsa, , Bulgaria
ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry"
Plovdiv, , Bulgaria
UMHAT Plovdiv AD
Plovdiv, , Bulgaria
MHAT "Silistra"AD
Silistra, , Bulgaria
Medical Center "INTERMEDICA"ООD
Sofia, , Bulgaria
LTD Health
Batumi, , Georgia
Jsc "Evex Clinics"
Kutaisi, , Georgia
Rustavi N2 Medical Diagnostic Center
Rustavi, , Georgia
Clinic "GIDMEDI"
Tbilisi, , Georgia
JSC "Evex clinics"
Tbilisi, , Georgia
Raymann LLC
Tbilisi, , Georgia
The Mikolowska Medical Center
Katowice, , Poland
Provita Sp. z o.o.
Katowice, , Poland
Medistica Osteomed
Krakow, , Poland
PROVITA Specialised Gynecology and Sexology Practice
Lublin, , Poland
Sexology and Pathology of Intercourse Clinic
Warsaw, , Poland
Ryszard Smoliński's Medical Cabinet
Wroclaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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FM71
Identifier Type: -
Identifier Source: org_study_id
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