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Study of Teverelix DP on Prostate Volume, Urinary Function and Clinical Outcomes Following Acute Urinary Retention

ConditionsAcute Urinary RetentionBenign Prostate Hypertrophy(BPH)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age45+
SponsorAntev Ltd.

About this trial

This randomized, double-blind, placebo-controlled Phase 2 study is evaluating Teverelix DP in men following a first episode of acute urinary retention (AUR) associated with benign prostatic hyperplasia (BPH), a population at risk of recurrent urinary retention and subsequent surgical or minimally invasive intervention.

The study is designed to evaluate the effects of Teverelix DP on total prostate volume and urinary function and to prospectively evaluate clinically meaningful outcomes including recurrent AUR, BPH-related surgical or minimally invasive intervention, protocol-defined treatment failure and clinical benefit.

Participants will be randomized to one of four treatment groups evaluating two active Teverelix DP regimens: 90 mg administered intramuscularly (IM) and 120 mg administered subcutaneously (SC) and their respective matched placebo controls.

The primary endpoint is percent change from baseline in total prostate volume (TPV) at Week 12. Participants will continue to be evaluated during the 28-week treatment period for urinary function and prospectively defined clinical outcomes, including recurrent AUR, BPH-related intervention, treatment failure and clinical benefit, and will be followed through Week 52 for protocol-defined longer-term assessments and safety follow-up.

The study is designed to characterize biological activity, urinary function, clinical outcomes, safety and the relative treatment effects of the two Teverelix DP regimens to inform dose and route selection and subsequent clinical development.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male aged 45 years or older

Having given his written consent

Successful TWOC as defined by successful voiding with a minimum residual volume

Having had a first episode of spontaneous acute urinary retention within 6 days of study screening visit.

Disqualifiers

Participated in another investigational study within 3 months before recruitment

AUR due to i.e. postoperative retention following major abdominal/pelvis/spinal surgery

Neurological related AUR

Contraindication to the use of alpha blockers

Trial design

Design model

Parallel

Treatments tested in this trial

  • Teverelix DP

    Drug

    Single dose at Day 1 of 90 mg injection IM

  • Teverelix DP Placebo

    Drug

    Single dose at Day 1 of 90 mg injection IM

  • Teverelix DP

    Drug

    Single dose at Day 1 of 120 mg injection SC

  • Teverelix DP Placebo

    Drug

    Single dose at Day 1 of 120 mg injection SC

Treatment groups

126 Participants
are divided into 4 treatment groups
Group A: Teverelix DP 90 mg IMActive comparator 1 intervention
Group B: Teverelix DP 120 mg SCActive comparator 1 intervention
Group C: Teverelix DP placebo 90 mg IMPlacebo comparator 1 intervention
Group D: Teverelix DP placebo 120 mg SCPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change from Baseline in Total Prostate Volume (TPV) at Week 12

Percent change from baseline in total prostate volume as assessed by transrectal ultrasound.

Time frame
Change from baseline to Week 12

Secondary outcomes

1

To assess the AUR clinical benefit rate of Teverelix DP after a single dose

The proportion of patients meeting all of the following criteria during the 28-week treatment period and the 52-week observation period: * No relapse of AUR; * No need or indication for surgical intervention; and * No occurrence of treatment failure (PVR \>300 mL with Qmax \<10 mL/sec).

Time frame
From dosing to week 52
2

Evaluate the durability of prostate volume reduction following a single dose of Teverelix DP

Percent change in total prostate volume

Time frame
Change from baseline to week 52
3

Change from baseline in post-void residual volume (PVR) (mL), assessed by ultrasound.

Time frame
Change from baseline to week 28
4

Change from baseline in maximum urinary flow rate (Qmax) (mL/sec), using Uroflowmetry.

Time frame
Change from baseline to week 28

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Antev Ltd.

Lead sponsor

Source ClinicalTrials.gov

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