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

NCT04984993 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2023-09-21

Study results available
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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.

Conditions

Interventions

DEVICE

MED3000 (Male)

Gel formulation

DRUG

Tadalafil 5mg (Male)

Tablets

DEVICE

MED3000 (Female)

Gel formulation

DRUG

Tadalafil 5mg (Female)

Tablets

Sponsors & Collaborators

  • Futura Medical Developments Ltd.

    lead INDUSTRY

Principal Investigators

  • Arthur Burnett, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2022-07-13
Completion
2022-07-13
FDA Device
Yes

Countries

  • United States
  • Bulgaria
  • Georgia
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04984993 on ClinicalTrials.gov