Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biozeus Biopharmaceutical S.A.
• Treatments: Tadalafil

Criteria

Inclusion Criteria:

1. Men between the ages of 40 and 65 years;

2. Exclusive heterosexual men, regardless of race or social class.

3. PR due to prostate cancer without metastasis;

4. PR performed less than 30 days before the screening visit;

5. Erectile function prior to normal PR, defined as IIEF questionnaire with more than 22 points in domain A;

6. Stable sexual partner (more than 2 months prior to PR), and intention to maintain the relationship during the study.

Exclusion Criteria:

1. Prostate cancer in TNM stage classified as T3 or T4.

2. PR of the perineal type;

3. Necessity of other therapy for prostate cancer than PR, including radiation therapy or hormone therapy;

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

5. Prior spinal cord injury with lower limb paralysis;

6. Current male hormone use, or hypogonadism, defined by total testosterone below 8 nmol/L (2300 pg/mL) or total testosterone between 8 and 11 nmol/L (2300 and 3170 pg/mL) and free testosterone < 220 pmol/L (< 64 ng/dL);

7. Patients with current depression, characterized by use or need for use of antidepressants.

8. Presence of genital lesions (such as severe penile fibrosis or Peyronie's disease) or active sexually transmitted disease (STD) (such as herpes, gonorrhea, candidiasis, HPV, and others) that impair analysis of local adverse effects on the genitalia;

9. Use of topical medications in the genital region that may interfere in the PSI evaluation, as well as in its absorption or drug interaction;

10. Possession of penile prosthesis;

11. History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patient with heart diseases (including history of angina and/or heart failure) and nephropathies;

12. Current use of nitrates, such as propatilnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®, Nitronal®, Tridil®) and isosorbitol dinitrate (Isocord®);

13. Findings on ECG and/or laboratory tests that, in the Investigator's criteria, are considered significant and offer risk to the research volunteer's participation or may hinder the study analyses;

14. BP outside the limits considered safe: SBP below 90 mmHg or above 170 mmHg; or DBP below 50 mmHg or above 100 mmHg, except situations such as "white coat syndrome";

15. Diseases that can cause priapism, such as sickle cell anemia, multiple myeloma, or leukemia;16. History of priapism, defined as painful erection for more than 6 hours;

17. Current relevant diarrhea, defined as duration over four weeks, association with abdominal pain or dysabsortive syndrome, or presence of mucus, pus, or blood in the stool;

18. Known hypersensitivity to tadalafil and/or BZ371A;