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

July 27, 2026 updated by: Antev Ltd.

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male aged 45 years or older
  2. Having given his written consent
  3. Successful TWOC as defined by successful voiding with a minimum residual volume
  4. Having had a first episode of spontaneous acute urinary retention within 6 days of study screening visit.
  5. Prostate volume >40 g (assessed by TRUS)
  6. 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

  7. Agrees to practice contraception during the entire study treatment period and for 3 months after the last dose of IMP is administered:

    1. Either by using double barrier contraception and in compliance with local guidelines,
    2. 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.

  8. Must be treatment naïve to GnRH analogues

Exclusion Criteria:

  1. Participated in another investigational study within 3 months before recruitment
  2. AUR due to i.e. postoperative retention following major abdominal/pelvis/spinal surgery
  3. Neurological related AUR
  4. Contraindication to the use of alpha blockers
  5. Previous prostate or urethral surgery
  6. Previous histological or clinical diagnosis of prostate cancer
  7. Any unstable co-existing medical condition

  8. Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values:

    1. Liver function test (aspartate aminotransferase [ASAT/SGOT], alanine aminotransferase [ALAT/SGPT]), exceeding >2X the upper limit of the normal (ULN) range
    2. Total bilirubin exceeding >1.5X the upper limit of the normal (ULN) range
    3. 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.

  9. Has congenital long QT syndrome or ECG abnormalities at screening of:

    1. Q-wave infarction, unless identified ≥6 months before screening
    2. 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
    3. 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)
  10. History or current evidence of alcohol or drug abuse within the last 12 months
  11. Prostate Specific Antigen (PSA) greater than 20ng/ml
  12. Use of suprapubic catheterization after failed urethral catheterization
  13. Neurogenic bladder dysfunction, confirmed or suspected, irrespective of etiology
  14. Isolated bladder neck disease
  15. Acute or chronic prostatitis
  16. Confirmed or suspected urethral stricture
  17. Known bladder stones

  18. Use of the following medications prior to and during study participation:

    1. Any other IMP (within 3 months of enrolment)
    2. 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)
    3. Anti-androgen therapy (within 3 months of enrolment)
    4. T replacement therapy (within 3 months of enrolment)
    5. 5α-reductase inhibitor treatment etc. (within 25 weeks prior to screening: dutasteride; within 12 weeks prior to screening: finasteride (and others))
    6. Bethanechol chloride
    7. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Teverelix DP 90 mg IM
Drug: Teverelix DP
Single dose at Day 1 of 90 mg injection IM
Drug: Teverelix DP
Single dose at Day 1 of 120 mg injection SC
Active Comparator: Teverelix DP 120 mg SC
Drug: Teverelix DP
Single dose at Day 1 of 90 mg injection IM
Drug: Teverelix DP
Single dose at Day 1 of 120 mg injection SC
Placebo Comparator: Teverelix DP placebo 90 mg IM
Drug: Teverelix DP Placebo
Single dose at Day 1 of 90 mg injection IM
Drug: Teverelix DP Placebo
Single dose at Day 1 of 120 mg injection SC
Placebo Comparator: Teverelix DP placebo 120 mg SC
Drug: Teverelix DP Placebo
Single dose at Day 1 of 90 mg injection IM
Drug: Teverelix DP Placebo
Single dose at Day 1 of 120 mg injection SC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change from Baseline in Total Prostate Volume (TPV) at Week 12
Time Frame: Change from baseline to Week 12
Percent change from baseline in total prostate volume as assessed by transrectal ultrasound.
Change from baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess the AUR clinical benefit rate of Teverelix DP after a single dose
Time Frame: From dosing to week 52

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).
From dosing to week 52
Evaluate the durability of prostate volume reduction following a single dose of Teverelix DP
Time Frame: Change from baseline to week 52
Percent change in total prostate volume
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 to week 28
Change from baseline in maximum urinary flow rate (Qmax) (mL/sec), using Uroflowmetry.
Time Frame: Change from baseline to week 28
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
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
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)
Time Frame: From Day 1 through study completion (an average of 1 year)
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).
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.
Time Frame: From Day 1 through study completion (an average of 1 year)
PVR volume measurements will be taken at various timepoints in the study to assess the time taken for PVR >60% of total bladder volume
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).
Time Frame: From Day 1 through study completion (an average of 1 year)
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.
From Day 1 through study completion (an average of 1 year)
To assess progression of BPH-related symptoms.
Time Frame: Change from Day 1 through study completion (an average of 1 year)
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.
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)
From Day 1 through study completion (an average of 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Antev Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANT-2111-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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