Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

ConditionsErectile Dysfunction Following Radical Prostatectomy Erectile Dysfunction Prostate Cancer Radical Prostatectomy

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexMale

Age40-65

SponsorBiozeus Biopharmaceutical S.A.

About this trial

To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.

Eligibility criteria

Qualifiers

Men between the ages of 40 and 65 years;

Exclusive heterosexual men, regardless of race or social class.

RP due to prostate cancer without metastasis;

RP performed less than 60 days before the screening visit;

Disqualifiers

Prostate cancer in TNM stage classified as T3 or T4.

Perineal and/or open RP;

Necessity of other therapy for prostate cancer than RP, including radiation therapy or hormone therapy;

Uncontrolled diabetes at screening visit (HbA1C > 10%);

Trial design

Treatments tested in this trial

Tadalafil 5mg
BZ371A
Oral Placebo
Topical Placebo

Treatment groups

72 Participants

are divided into 3 treatment groups

Sponsors and collaborators

Biozeus Biopharmaceutical S.A.

Lead sponsor

Source ClinicalTrials.gov