Health TrialsbyHealthPanel

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

ConditionsErectile Dysfunction Following Radical ProstatectomyErectile DysfunctionProstate CancerRadical 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tadalafil 5mg

    Drug

    Daily oral administration of tadalafil 5mg

  • BZ371A

    Drug

    Topical application of 1.5 mL of BZ371A in a concentration of 5mg/mL

  • Oral Placebo

    Drug

    Oral administration of a placebo pill

  • Topical Placebo

    Drug

    Topical application of 1.5 mL of placebo

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: Daily oral Tadalafil 5mg + Topical PlaceboActive comparator 2 interventions
Group B: Daily oral placebo + topical BZ371AExperimental treatment 2 interventions
Group C: Daily oral Tadalafil 5mg + topical BZ371AActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in Assisted Erectile Function

Measurement of the ability to to have an erection that allows sexual intercourse, under use of medication. This will be assessed by using the IIEF questionnaire, domain A (erectile function section) (IIEF-EF).

Time frame
From up to 30 days before Baseline, Baseline, 30 days, 60 days

Secondary outcomes

1

Change in successful vaginal intercourse rate

Rate of successful vaginal intercourse will be assessed through question 3 of the SEP (Sexual Encouter Profile) questionnaire.

Time frame
From up to 30 days before Baseline, Baseline, 30 days, 60 days
2

Change in quality of sexual intercourse

Quality of sexual intercourse, through the EDITS questionnaire (Erectile Dysfunction Inventory of Treatment Satisfaction);

Time frame
30 days, 60 days
3

Change in penile extension

Penile extension, measured with a ruler.

Time frame
Baseline, 30 days, 60 days
4

Penile Blood flow increase

Increased blood flow, assessed by peak systolic velocity (PSV), end-diastolic velocity (EDV) and resistivity index (RI) assessed by Doppler examination;

Time frame
From up to 30 days before Baseline, Baseline, 30 days, 60 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biozeus Biopharmaceutical S.A.

Lead sponsor

Source ClinicalTrials.gov
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