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

Last updated: September 18, 2023
Sponsor: Futura Medical Developments Ltd.
Overall Status: Completed

Phase

3

Condition

Impotence

Male Hormonal Deficiencies/abnormalities

Infertility

Treatment

Tadalafil 5mg (Female)

Tadalafil 5mg (Male)

MED3000 (Male)

Clinical Study ID

NCT04984993
FM71
  • Ages 22-70
  • Male

Study 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

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 6months.

Exclusion

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, inthe opinion of the Principal Investigator, is likely to affect the patient's abilityto complete the investigation or precludes the patient's participation in theinvestigation.

Study Design

Total Participants: 116
Treatment Group(s): 4
Primary Treatment: Tadalafil 5mg (Female)
Phase: 3
Study Start date:
September 14, 2021
Estimated Completion Date:
July 13, 2022

Connect with a study center

  • Medical Center "Asklepii"OOD

    Dupnitsa, 2600
    Bulgaria

    Site Not Available

  • UMHAT Plovdiv AD

    Plovdiv,
    Bulgaria

    Site Not Available

  • ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry"

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • MHAT "Silistra"AD

    Silistra, 7500
    Bulgaria

    Site Not Available

  • Medical Center "INTERMEDICA"ООD

    Sofia, 1000
    Bulgaria

    Site Not Available

  • LTD Health

    Batumi,
    Georgia

    Site Not Available

  • Jsc "Evex Clinics"

    Kutaisi, 4600
    Georgia

    Site Not Available

  • Rustavi N2 Medical Diagnostic Center

    Rustavi, 3700
    Georgia

    Site Not Available

  • Clinic "GIDMEDI"

    Tbilisi, 0112
    Georgia

    Site Not Available

  • JSC "Evex clinics"

    Tbilisi, 0160
    Georgia

    Site Not Available

  • Raymann LLC

    Tbilisi, 0162
    Georgia

    Site Not Available

  • Provita Sp. z o.o.

    Katowice, 40-611
    Poland

    Site Not Available

  • The Mikolowska Medical Center

    Katowice, 40-065
    Poland

    Site Not Available

  • Medistica Osteomed

    Kraków, 30-074
    Poland

    Site Not Available

  • PROVITA Specialised Gynecology and Sexology Practice

    Lublin, 20-93
    Poland

    Site Not Available

  • Sexology and Pathology of Intercourse Clinic

    Warsaw, 05-077
    Poland

    Site Not Available

  • Ryszard Smoliński's Medical Cabinet

    Wrocław, 53-532
    Poland

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Site Not Available

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