Trial Outcomes & Findings for Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH) (NCT NCT00663858)
NCT ID: NCT00663858
Last Updated: 2011-01-17
Results Overview
IPSS score of BPH symptoms 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 overall score range: 0 points (best) to 35 points (worst)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
420 participants
Primary outcome timeframe
Baseline and 52 weeks
Results posted on
2011-01-17
Participant Flow
Participant milestones
| Measure |
Cetrorelix 78+78
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
|
CET 78+Placebo
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
|
Placebo
Placebo on Week 0, 2, 26 and 28.
|
|---|---|---|---|
|
Overall Study
STARTED
|
212
|
106
|
102
|
|
Overall Study
COMPLETED
|
178
|
96
|
82
|
|
Overall Study
NOT COMPLETED
|
34
|
10
|
20
|
Reasons for withdrawal
| Measure |
Cetrorelix 78+78
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
|
CET 78+Placebo
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
|
Placebo
Placebo on Week 0, 2, 26 and 28.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
1
|
6
|
|
Overall Study
Lack of Efficacy
|
5
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
3
|
|
Overall Study
Protocol Violation
|
5
|
3
|
4
|
|
Overall Study
Other
|
8
|
2
|
4
|
Baseline Characteristics
Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Baseline characteristics by cohort
| Measure |
Cetrorelix 78+78
n=212 Participants
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
|
CET 78+Placebo
n=106 Participants
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
|
Placebo
n=102 Participants
Placebo on Week 0, 2, 26 and 28.
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
101 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
183 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
111 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
237 Participants
n=483 Participants
|
|
Age Continuous
|
66.58 years
STANDARD_DEVIATION 8.16 • n=93 Participants
|
66.50 years
STANDARD_DEVIATION 7.29 • n=4 Participants
|
67.72 years
STANDARD_DEVIATION 7.17 • n=27 Participants
|
66.83 years
STANDARD_DEVIATION 7.71 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=93 Participants
|
106 Participants
n=4 Participants
|
102 Participants
n=27 Participants
|
420 Participants
n=483 Participants
|
|
Region of Enrollment
France
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
|
Region of Enrollment
Belarus
|
37 participants
n=93 Participants
|
18 participants
n=4 Participants
|
18 participants
n=27 Participants
|
73 participants
n=483 Participants
|
|
Region of Enrollment
Czech Republic
|
33 participants
n=93 Participants
|
15 participants
n=4 Participants
|
19 participants
n=27 Participants
|
67 participants
n=483 Participants
|
|
Region of Enrollment
Macedonia, The Former Yugoslav Republic of
|
6 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
12 participants
n=483 Participants
|
|
Region of Enrollment
Romania
|
54 participants
n=93 Participants
|
28 participants
n=4 Participants
|
26 participants
n=27 Participants
|
108 participants
n=483 Participants
|
|
Region of Enrollment
Bulgaria
|
41 participants
n=93 Participants
|
20 participants
n=4 Participants
|
20 participants
n=27 Participants
|
81 participants
n=483 Participants
|
|
Region of Enrollment
Germany
|
15 participants
n=93 Participants
|
7 participants
n=4 Participants
|
6 participants
n=27 Participants
|
28 participants
n=483 Participants
|
|
Region of Enrollment
Netherlands
|
23 participants
n=93 Participants
|
13 participants
n=4 Participants
|
10 participants
n=27 Participants
|
46 participants
n=483 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
3 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and 52 weeksIPSS score of BPH symptoms 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 overall score range: 0 points (best) to 35 points (worst)
Outcome measures
| Measure |
Cetrorelix 78+78
n=207 Participants
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
|
CET 78+Placebo
n=104 Participants
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
|
Placebo
n=100 Participants
Placebo on Week 0, 2, 26 and 28.
|
|---|---|---|---|
|
International Prostate Symptom Score (IPSS)
|
-6.2 Units on a scale
Standard Deviation 5.68
|
-5.1 Units on a scale
Standard Deviation 5.18
|
-5.7 Units on a scale
Standard Deviation 6.04
|
Adverse Events
Cetrorelix 78+78
Serious events: 8 serious events
Other events: 10 other events
Deaths: 0 deaths
CET 78+Placebo
Serious events: 7 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetrorelix 78+78
n=212 participants at risk
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
|
CET 78+Placebo
n=106 participants at risk
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
|
Placebo
n=102 participants at risk
Placebo on Week 0, 2, 26 and 28.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/212
|
0.94%
1/106 • Number of events 1
|
0.00%
0/102
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/212
|
0.94%
1/106 • Number of events 1
|
0.00%
0/102
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/212
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/212
|
0.94%
1/106 • Number of events 1
|
0.00%
0/102
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/212
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.47%
1/212 • Number of events 1
|
0.00%
0/106
|
0.00%
0/102
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/212
|
0.94%
1/106 • Number of events 1
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/212
|
0.00%
0/106
|
0.98%
1/102 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.47%
1/212 • Number of events 1
|
0.00%
0/106
|
0.00%
0/102
|
|
Eye disorders
Glaucoma
|
0.47%
1/212 • Number of events 1
|
0.00%
0/106
|
0.00%
0/102
|
|
Infections and infestations
Herpes zoster ophtalmic
|
0.47%
1/212 • Number of events 1
|
0.00%
0/106
|
0.00%
0/102
|
|
Vascular disorders
Infarction
|
0.00%
0/212
|
0.94%
1/106 • Number of events 1
|
0.00%
0/102
|
|
Vascular disorders
Intermittent claudication
|
0.47%
1/212 • Number of events 1
|
0.00%
0/106
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protusion
|
0.00%
0/212
|
0.94%
1/106 • Number of events 1
|
0.00%
0/102
|
|
Cardiac disorders
Myocardial infartion
|
0.00%
0/212
|
0.00%
0/106
|
2.0%
2/102 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.47%
1/212 • Number of events 1
|
0.00%
0/106
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
1/212 • Number of events 1
|
0.00%
0/106
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/212
|
0.94%
1/106 • Number of events 1
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.47%
1/212 • Number of events 1
|
0.00%
0/106
|
0.00%
0/102
|
|
Gastrointestinal disorders
Subileus
|
0.47%
1/212 • Number of events 1
|
0.00%
0/106
|
0.00%
0/102
|
|
Nervous system disorders
Transient ischemic attack
|
0.47%
1/212 • Number of events 1
|
0.00%
0/106
|
0.00%
0/102
|
Other adverse events
| Measure |
Cetrorelix 78+78
n=212 participants at risk
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
|
CET 78+Placebo
n=106 participants at risk
78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.
|
Placebo
n=102 participants at risk
Placebo on Week 0, 2, 26 and 28.
|
|---|---|---|---|
|
Infections and infestations
Influenza
|
4.7%
10/212
|
4.7%
5/106
|
5.9%
6/102
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60