A Phase 3 interventional study of Cetrorelix 78 mg + 78 mg and Cetrorelix 78 mg + 52 mg in Benign Prostatic Hypertrophy, sponsored by AEterna Zentaris. Terminated at 68 sites in 4 countries. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-08-03.
Sponsored by AEterna Zentaris · Phase 3, Interventional, and Treatment
Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.
For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).
The objectives of the study are to develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms.
Patients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS).
Patients will then be allocated to study drug in a double-blind, randomized, double-dummy, placebo-controlled fashion.
Patients will be administered an IM injection of study drug at Week 0, 2, 26 and 28 and will be followed up to Week 52.
Then, in an open label fashion, patients will be administered an IM injection of study drug at Week 52, 54, 78 and 80 and will be followed up to Week 90.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 667 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →AEterna Zentaris is the lead sponsor of 34 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Treatment course 1: Cetrorelix 78 mg + 78 mg * Week 0: 52 mg CET (2 injections) * Week 2: 26 mg CET (1 injection) Treatment course 2: * Week 26: 52 mg CET (2 injections) * Week 28: 26 mg CET(1 injection) 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
Drug: Cetrorelix 78 mg + 78 mg
Treatment course 1: Cetrorelix 78 mg + 52 mg * Week 0: 52 mg CET (2 injections) * Week 2: 26 mg CET (1 injection) Treatment course 2: * Week 26: 52 mg CET (2 injections) * Week 28: Placebo (1 injection) 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
Drug: Cetrorelix 78 mg + 52 mg · Drug: Placebo
Treatment course 1: * Week 0: placebo (2 injections) * Week 2: placebo (1 injection) Treatment course 2: * Week 26: placebo (2 injections) * Week 28: placebo (1 injection) 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
Drug: Placebo
Also known as: CET, AEZS-102
Also known as: CET, AEZS-102
Also known as: Placebo (PLA)
International Prostate Symptoms Score (IPSS)
The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 points (best) to 35 points (worst)
Time frame: Baseline and 52 weeks
Time Course of Quality of Life
The time course of quality of life: assessed by the following disease specific quality of life:"If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that?" The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible.
Time frame: Quality of life assessment in the following weeks: 4,12,26,30,38,46,52
| Milestone | Cetrorelix 78+78 | Cetrorelix 78+52 | Placebo |
|---|---|---|---|
| Started | 219 | 230 | 218 |
| Completed | 173 | 177 | 171 |
| Not completed | 46 | 53 | 47 |
| Withdrew: Adverse event | 11 | 18 | 9 |
| Withdrew: Lack of efficacy | 1 | 2 | 2 |
| Withdrew: Other | 16 | 13 | 14 |
| Withdrew: Withdrawal by subject | 17 | 18 | 21 |
| Withdrew: Protocol violation | 1 | 2 | 1 |
The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 points (best) to 35 points (worst)
| Units on a scale | Cetrorelix 78+78 | Cetrorelix 78+52 | Placebo |
|---|---|---|---|
| International Prostate Symptoms Score (IPSS) | -4.0 ± 6.61 | -3.7 ± 5.90 | -3.8 ± 6.22 |
The time course of quality of life: assessed by the following disease specific quality of life:"If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that?" The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible.
| score on a scale | Treatment Group A: Cetrorelix (CET) 78 mg + 78 mg | Treatment Group B: CET 78 mg + 52 mg | Treatment Group C: Placebo |
|---|---|---|---|
| Week 4 | -0.33 ± 1.16 | -0.42 ± 1.09 | -0.35 ± 1.00 |
| Week 12 | -0.52 ± 1.21 | -0.67 ± 1.25 | -0.47 ± 1.05 |
| Week 26 | -0.48 ± 1.18 | -0.70 ± 1.41 | -0.46 ± 1.07 |
| Week 30 | -0.64 ± 1.20 | -0.71 ± 1.40 | -0.58 ± 1.24 |
| Week 38 | -0.62 ± 1.20 | -0.77 ± 1.38 | -0.59 ± 1.22 |
| Week 46 | -0.71 ± 1.28 | -0.67 ± 1.41 | -0.58 ± 1.20 |
| Week 52 | -0.55 ± 1.25 | -0.62 ± 1.39 | -0.60 ± 1.11 |
Collected over Adverse events (AEs) related information will be collected during the entire course of the study. AEs will be reported as treatment-emergent adverse event (TEAE) if their start date ranges between the date of randomization and 3 months after the last administration of the study treatment. Adverse events (AEs) will be monitored from screening up to 90 weeks.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cetrorelix 78+78 | — | 11/219 (5%) | 177/219 (80.8%) |
| Cetrorelix 78+52 | — | 16/230 (7%) | 179/230 (77.8%) |
| Placebo | — | 21/218 (9.6%) | 169/218 (77.5%) |
| Event | Cetrorelix 78+78 | Cetrorelix 78+52 | Placebo |
|---|---|---|---|
| coronary artery diseaseCardiac disorders | 1/219 | 4/230 | 0/218 |
| prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/219 | 4/230 | 2/218 |
| cerebrovascular accidentNervous system disorders | 0/219 | 0/230 | 2/218 |
| cholelithiasisHepatobiliary disorders | 0/219 | 0/230 | 2/218 |
| transient ischaemic attackNervous system disorders | 0/219 | 0/230 | 2/218 |
| angina pectorisCardiac disorders | 0/219 | 2/230 | 0/218 |
| abdominal wall abscessInfections and infestations | 0/219 | 0/230 | 1/218 |
| astheniaGeneral disorders | 0/219 | 0/230 | 1/218 |
| atrial flutterCardiac disorders | 0/219 | 0/230 | 1/218 |
| bursitisMusculoskeletal and connective tissue disorders | 0/219 | 0/230 | 1/218 |
| Event | Cetrorelix 78+78 | Cetrorelix 78+52 | Placebo |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 17/219 | 23/230 | 19/218 |
| Injection site painGeneral disorders | 21/219 | 17/230 | 8/218 |
| HeadacheNervous system disorders | 18/219 | 15/230 | 16/218 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 16/219 | 11/230 | 6/218 |
| Upper respiratory infectionInfections and infestations | 16/219 | 15/230 | 13/218 |
| DiarrheaGastrointestinal disorders | 12/219 | 15/230 | 6/218 |
| PSA increasedInvestigations | 10/219 | 15/230 | 5/218 |
| Back painMusculoskeletal and connective tissue disorders | 14/219 | 14/230 | 14/218 |
| RashSkin and subcutaneous tissue disorders | 13/219 | 5/230 | 6/218 |
| HypertensionVascular disorders | 12/219 | 9/230 | 12/218 |
| Age, Categorical(Participants) | Cetrorelix 78+78 | Cetrorelix 78+52 | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 109 | 126 | 111 | 346 |
| >=65 years | 110 | 104 | 107 | 321 |
| Age, Continuous(years) | Cetrorelix 78+78 | Cetrorelix 78+52 | Placebo | Total |
|---|---|---|---|---|
| Mean | 63.86 ± 8.27 | 64.04 ± 7.54 | 64.20 ± 7.76 | 64.03 ± 7.84 |
| Sex: Female, Male(Participants) | Cetrorelix 78+78 | Cetrorelix 78+52 | Placebo | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 219 | 230 | 218 | 667 |
| Region of Enrollment(participants) | Cetrorelix 78+78 | Cetrorelix 78+52 | Placebo | Total |
|---|---|---|---|---|
| United States | 142 | 148 | 140 | 430 |
| Canada | 38 | 42 | 39 | 119 |
| Bulgaria | 11 | 12 | 12 | 35 |
| Germany | 28 | 28 | 27 | 83 |
This study is terminated, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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AEterna Zentaris