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

NCT07733934 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-07-29

No results posted yet for this study

Summary

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.

Conditions

  • Benign Prostate Hypertrophy(BPH)
  • Acute Urinary Retention

Interventions

DRUG

Teverelix DP

Single dose at Day 1 of 90 mg injection IM

DRUG

Teverelix DP Placebo

Single dose at Day 1 of 90 mg injection IM

DRUG

Teverelix DP

Single dose at Day 1 of 120 mg injection SC

DRUG

Teverelix DP Placebo

Single dose at Day 1 of 120 mg injection SC

Sponsors & Collaborators

  • Antev Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-05-31
Completion
2028-05-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07733934 on ClinicalTrials.gov