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

Futura Medical

Status and phase

Completed

Phase 3

Conditions

Erectile Dysfunction

Treatments

Drug: Tadalafil 5mg (Female)

Device: MED3000 (Female)

Device: MED3000 (Male)

Drug: Tadalafil 5mg (Male)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04984993

FM71

Details and patient eligibility

About

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.

Enrollment

116 patients

Sex

Male

Ages

22 to 70 years old

Volunteers

No Healthy Volunteers

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.