A Phase 2 interventional study of Teverelix DP and Teverelix DP Placebo in Acute Urinary Retention and Benign Prostate Hypertrophy(BPH), sponsored by Antev Ltd.. Not yet recruiting. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Antev Ltd. · Phase 2, Interventional, and Treatment
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.
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 126 is above the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Antev Ltd. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Agrees to practice during the entire study treatment period and for 3 months after the last dose of IMP is administered:
i. Note: Periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner with ] and withdrawal are not acceptable methods of contraception.
Exclusion Criteria:
Has abnormal screening and/or baseline laboratory values that suggest a underlying disease, or the following laboratory values:
Has congenital long syndrome or abnormalities at screening of:
Note: Cardiac arrhythmia grading:
Use of the following medications prior to and during study participation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Teverelix DP
Drug: Teverelix DP
Drug: Teverelix DP Placebo
Drug: Teverelix DP Placebo
Single dose at Day 1 of 90 mg injection IM
Single dose at Day 1 of 90 mg injection IM
Single dose at Day 1 of 120 mg injection SC
Single dose at Day 1 of 120 mg injection SC
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
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
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
Change from baseline in post-void residual volume (PVR) (mL), assessed by ultrasound.
Time frame: Change from baseline to week 28
Change from baseline in maximum urinary flow rate (Qmax) (mL/sec), using Uroflowmetry.
Time frame: Change from baseline to week 28
Explore the correlation between change prostate volume and change in post-void residual volume (PVR) (mL)
Time frame: Change from baseline to week 28
Explore the correlation between change prostate volume and change in maximum urinary flow rate (Qmax) (mL/sec)
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 through study completion (an average of 1 year)
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for May 2028, 20 months later.
Of 17 phase 2 interventional studies under Prostatic Hyperplasia, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 76. This study's planned 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Antev Ltd.