Acute Urinary RetentionPhase 2NCT07733934
Study of Teverelix DP on Prostate Volume, Urinary Function and Clinical Outcomes Following Acute Urinary Retention
A Phase 2 study testing Teverelix DP in people with Acute Urinary Retention and Benign Prostate Hypertrophy(BPH), run by Antev Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Acute Urinary Retention, Benign Prostate Hypertrophy(BPH)
- What is being tested?
- Teverelix DP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to May 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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
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- 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
- Note: Cardiac arrhythmia grading:
- Bradyarrhythmias (HR <60/min)
- Tachyarrhythmias (HR >100/min
- Supraventricular arrhythmias - arrhythmias that originate in the sinoatrial node, atrial myocardium or atrioventricular node (regular QRS complex)
- Ventricular arrhythmias - arrhythmias that originate below the atrioventricular node (wide QRS complex)
- History or current evidence of alcohol or drug abuse within the last 12 months
- Prostate Specific Antigen (PSA) greater than 20ng/ml
- Use of suprapubic catheterization after failed urethral catheterization
- Neurogenic bladder dysfunction, confirmed or suspected, irrespective of etiology
- Isolated bladder neck disease
- Acute or chronic prostatitis
- Confirmed or suspected urethral stricture
- Known bladder stones
- Use of the following medications prior to and during study participation:
- Any other IMP (within 3 months of enrolment)
- Herbal medications known to have anti-androgenic effects (e.g. red reishi, licorice, white peony, green tea, spearmint, black cohosh, chaste tree, saw palmetto, etc) (within 3 months of enrolment)
- Anti-androgen therapy (within 3 months of enrolment)
- T replacement therapy (within 3 months of enrolment)
- 5α-reductase inhibitor treatment etc. (within 25 weeks prior to screening: dutasteride; within 12 weeks prior to screening: finasteride (and others))
- Bethanechol chloride
- Any other medication or herbal product that may affect hormone levels and might, therefore, confound interpretation of the study results (e.g. St. John's wort) (within 3 months of enrolment)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-centre Study to Evaluate the Effects of Teverelix DP, a GnRH Antagonist, on Prostate Volume, Urinary Function and Clinical Outcomes in Men Following a First Episode of Acute Urinary Retention (AUR)
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.
Read more
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.
Read the detailed description
An interim analysis of the primary endpoint will be conducted after at least 50% of patients have completed their 12-week visit. The interim analysis may also be used to inform future development strategy for Teverelix DP. Should the interim data demonstrate supportive safety and pharmacodynamic trends, the Sponsor may consider expansion of the clinical development program into a confirmatory Phase 3 trial.
- Being tested
- Teverelix DP, Teverelix DP Placebo
- Keywords
- Prostatic Diseases, Teverelix, Acute urinary retention, Benign Prostate Hypertrophy, AUR, BPH
- Medical subject headings
- Prostatic Hyperplasia, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teverelix DPDrug
Single dose at Day 1 of 90 mg injection IM
Teverelix DP PlaceboDrug
Single dose at Day 1 of 90 mg injection IM
Teverelix DPDrug
Single dose at Day 1 of 120 mg injection SC
Teverelix DP PlaceboDrug
Single dose at Day 1 of 120 mg injection SC
| Study group | Role | What they receive |
|---|---|---|
| Teverelix DP 90 mg IM | Active comparator | Not described Receives: Drug: Teverelix DP |
| Teverelix DP 120 mg SC | Active comparator | Not described Receives: Drug: Teverelix DP |
| Teverelix DP placebo 90 mg IM | Placebo comparator | Not described Receives: Drug: Teverelix DP Placebo |
| Teverelix DP placebo 120 mg SC | Placebo comparator | Not described Receives: Drug: Teverelix DP Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to Week 12
Secondary outcomes (11)
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).
Measured: From dosing to week 52
Evaluate the durability of prostate volume reduction following a single dose of Teverelix DP
Percent change in total prostate volume
Measured: Change from baseline to week 52
Change from baseline in post-void residual volume (PVR) (mL), assessed by ultrasound.
Measured: Change from baseline to week 28
Change from baseline in maximum urinary flow rate (Qmax) (mL/sec), using Uroflowmetry.
Measured: Change from baseline to week 28
Explore the correlation between change prostate volume and change in post-void residual volume (PVR) (mL)
Measured: Change from baseline to week 28
Explore the correlation between change prostate volume and change in maximum urinary flow rate (Qmax) (mL/sec)
Measured: Change from baseline to week 28
Incidence of AUR recurrence according to Teverelix dose (90 mg vs 120 mg) and route of administration (IM vs SC)
Identifying the optimal dosing regimen and route of administration from the following; 90 mg or 120 mg of Teverelix DP and intramuscular (IM) or subcutaneous (SC).
Measured: From Day 1 through study completion (an average of 1 year)
To assess time to Post-void residual (PVR) >60% of total bladder volume, measured by ultrasound.
PVR volume measurements will be taken at various timepoints in the study to assess the time taken for PVR >60% of total bladder volume
Measured: From Day 1 through study completion (an average of 1 year)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of Teverelix DP in men with AUR secondary to benign prostatic hyperplasia (BPH).
Safety and tolerability will be evaluated by the incidence, nature, severity, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs), together with assessments of clinical laboratory parameters, vital signs, physical examinations, electrocardiograms (ECGs), concomitant medications, and any clinically significant findings observed throughout the study.
Measured: From Day 1 through study completion (an average of 1 year)
To assess progression of BPH-related symptoms.
The International Prostate Symptom Score (IPSS) will be used to assess progression of BPH-related symptoms. The total IPSS score is calculated by summing the scores from all seven questions, giving a range of 0 to 35. Change in IPSS score will be reviewed. Lower scores indicate fewer or less severe urinary symptoms, and higher scores indicate more severe urinary symptoms.
Measured: Change from Day 1 through study completion (an average of 1 year)
To assess the incidence of BPH-related minimally invasive procedures or surgeries. Procedure/surgery review will completed at visits throughout the study.
Measured: From Day 1 through study completion (an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antev Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733934
- Sponsor's protocol ID
- ANT-2111-02
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No