A Phase II single centre, open-label study investigating the pharmacokinetics, pharmacodynamics, efficacy and safety of a loading dose regimen of a new GnRH antagonist, Teverelix, long-acting formulation administered subcutaneously as two doses of 120 mg (given as 2 injections of 60 mg on Day 1 and repeated on Day 2) in patients with advanced prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005742-39-LT

Enrollment

Registered

2005-12-20

Start date

2006-02-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADVANCED PROSTATE CANCER

Interventions

Product Name: TEVERELIX Product Code: ARD-03

ARD-06 Pharmaceutical Form: Suspension for injection Concentration unit: mg milligram(s) Concentration number: 120-

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Histologically proven adenocarcinoma of the prostate - Androgen deprivation therapy suitable (advanced prostate cancer i.e. with local invasion or/and metastasis) - Signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Liver or renal function tests (ASAT/SGOT, ALAT/SGPT, total bilirubin, creatinine) exceeding twice the upper limit of the normal range, unless the elevation is attributed to hepatic metastasis - Any contraindication to the use of Teverelix LA - Life expectancy of less than 1 year - Baseline testosterone value below 2.31 ng/ml - Bilateral orchidectomy - Pre-existing hormone therapy or planned concomitant use of androgen deprivation therapy with any agent other than the investigational drug - Neurological, psychiatric disease, drug or alcohol abuse which could interfere with the subject’s proper compliance - Evidence of concurrent malignancy - Exposure to another investigational agent within the last month - Lack of ability or willingness to give informed consent - Anticipated non-availability for study visits/ procedures

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the duration of action of an initial "loading" dose regimen of Teverelix LA in terms of suppression of testosterone to below castrate level (0.5 ng/ml);Secondary Objective: - To assess the pharmacodynamics of teverelix in terms of ability to suppress and to maintain plasma testosterone levels below castration level (< 0.5 ng/ml) until (after week 3) 2 consecutive, increasing T levels above castration level with the latter one above 2 ng/ml, have been recorded - To assess the effects on Luteinizing Hormone (LH) - To assess the effects on Prostate Specific Antigen (PSA) - To assess the safety of Teverelix LA in terms of : - Local tolerability and - Systemic tolerability (adverse events and changes in laboratory parameters);Primary end point(s): Suppression of testosterone to castrate level (0.5 ng/ml)	—

Measure

Time frame

Main Objective: To assess the duration of action of an initial "loading" dose regimen of Teverelix LA in terms of suppression of testosterone to below castrate level (0.5 ng/ml);Secondary Objective: - To assess the pharmacodynamics of teverelix in terms of ability to suppress and to maintain plasma testosterone levels below castration level (< 0.5 ng/ml) until (after week 3) 2 consecutive, increasing T levels above castration level with the latter one above 2 ng/ml, have been recorded - To assess the effects on Luteinizing Hormone (LH) - To assess the effects on Prostate Specific Antigen (PSA) - To assess the safety of Teverelix LA in terms of : - Local tolerability and - Systemic tolerability (adverse events and changes in laboratory parameters);Primary end point(s): Suppression of testosterone to castrate level (0.5 ng/ml)

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Countries

Lithuania

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026