Phase 2 Clinical Trial to Evaluate Safety and Efficacy of BZ371A in a Gel Applied in Patients That Performed Radical Prostatectomy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: f
View:
• 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;
• Erectile function prior to normal RP, defined as IIEF questionnaire with more than 22 points in domain A;
• Stable sexual partner (more than 2 months prior to RP), and intention to maintain the relationship during the study.
• Continuous use of 5mg Tadalafil from the 30th up to the 60th day after RP.
Locations
Other Locations
Brazil
Hospital Urológica
RECRUITING
Belo Horizonte
Contact Information
Primary
Camilla NR Trindade, PhD
camilla.nunes@biozeus.com.br
+55(21)2523-9089
Time Frame
Start Date: 2023-11-22
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 72
Treatments
Active_comparator: Daily oral Tadalafil 5mg + Topical Placebo
Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical placebo
Experimental: Daily oral placebo + topical BZ371A
Patient that underwent Radical Prostatectomy will receive daily oral placebo and topical BZ371A
Active_comparator: Daily oral Tadalafil 5mg + topical BZ371A
Patient that underwent Radical Prostatectomy will receive daily oral Tadalafil 5mg and topical BZ371A
Related Therapeutic Areas
Sponsors
Leads: Biozeus Biopharmaceutical S.A.