Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction

Completed · Phase 3

Conditions studied: Erectile Dysfunction

In brief

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.

Key facts

Study ID

NCT04984993

Run by

Futura Medical Developments Ltd.

People needed

116

Starts

2021-09-14

Expected to finish

2022-07-13

Last updated by the study team

2023-09-21

Who can join

Age: 22 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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