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

NCT07733934 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: ANT-2111-02
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief 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

Acute Urinary Retention; Benign Prostate Hypertrophy(BPH)

Keywords

Prostatic Diseases; Teverelix; Acute urinary retention; Benign Prostate Hypertrophy; AUR; BPH

Outcome Measures

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.

  Change from baseline to Week 12

Secondary Outcomes (11)

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

  From dosing to week 52

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

  Change from baseline to week 52

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

  Change from baseline to week 28

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

  Change from baseline to week 28

• Explore the correlation between change prostate volume and change in post-void residual volume (PVR) (mL)

  Change from baseline to week 28

Study Arms (4)

Teverelix DP 90 mg IM

ACTIVE COMPARATOR

Drug: Teverelix DP

Teverelix DP 120 mg SC

ACTIVE COMPARATOR

Drug: Teverelix DP

Teverelix DP placebo 90 mg IM

PLACEBO COMPARATOR

Drug: Teverelix DP Placebo

Teverelix DP placebo 120 mg SC

PLACEBO COMPARATOR

Drug: Teverelix DP Placebo

Interventions

Teverelix DP DRUG

Single dose at Day 1 of 90 mg injection IM

Teverelix DP 90 mg IM

Teverelix DP Placebo DRUG

Single dose at Day 1 of 90 mg injection IM

Teverelix DP placebo 90 mg IM

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Cisgender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Prostate volume \>40 g (assessed by TRUS)
• Patients may initiate or continue alpha-blocker therapy at or before randomization. The same agent and dose should be continued throughout the treatment period where possible
• Agrees to practice contraception during the entire study treatment period and for 3 months after the last dose of IMP is administered:
• Either by using double barrier contraception and in compliance with local guidelines,
• or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the patient
• i. Note: Periodic abstinence \[e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner with childbearing potential\] and withdrawal are not acceptable methods of contraception.
• Must be treatment naïve to GnRH analogues

You may not qualify if:

• 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
• Previous prostate or urethral surgery
• Previous histological or clinical diagnosis of prostate cancer
• Any unstable co-existing medical condition
• Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values:
• Liver function test (aspartate aminotransferase \[ASAT/SGOT\], alanine aminotransferase \[ALAT/SGPT\]), exceeding \>2X the upper limit of the normal (ULN) range
• Total bilirubin exceeding \>1.5X the upper limit of the normal (ULN) range
• An estimated glomerular filtration rate (eGFR) \< 30 mL/min, based on creatinine clearance calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation normalised to an average surface area of 1.73m2, at the screening visit.
• Has congenital long QT syndrome or ECG abnormalities at screening of:
• Q-wave infarction, unless identified ≥6 months before screening
• Fridericia corrected QT interval (QTcF interval) \>480 msec. If QTcF is prolonged in a patient with a pacemaker, the patient may be enrolled in the study upon discussion with the project clinician
• If the QTcF interval is 450-480 msec, inclusive, in a patient with current use of medications with known effects on QT interval, the patient may be enrolled in the study following discussion with the Medical Lead

Sponsors & Collaborators

• Antev Ltd.: lead

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Ruhena Chowdhury, PhD

CONTACT

+4407491167075; rchowdhury@antev.co.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07