Trial Outcomes & Findings for Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH) (NCT NCT00670306)

Last Updated: 2011-04-05

Results Overview

International Prostate Symptom Score (IPSS) 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 - 35 points; absolute change from baseline to Week 26

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

528 participants

Primary outcome timeframe

Baseline and Week 26

Results posted on

2011-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	Cetrorelix 78 mg Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
Overall Study STARTED	528
Overall Study COMPLETED	473
Overall Study NOT COMPLETED	55

Reasons for withdrawal

Reasons for withdrawal
Measure	Cetrorelix 78 mg Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
Overall Study Adverse Event	8
Overall Study Lack of Efficacy	10
Overall Study Withdrawal by Subject	9
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	8
Overall Study incl/excl criterias did not meet	19

Baseline Characteristics

Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetrorelix 78 mg n=528 Participants Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	301 Participants n=99 Participants
Age, Categorical >=65 years	227 Participants n=99 Participants
Age Continuous	64.9 years STANDARD_DEVIATION 8.2 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	528 Participants n=99 Participants
Region of Enrollment United States	414 participants n=99 Participants
Region of Enrollment Canada	114 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline and Week 26

Population: Intention to treat (ITT) analysis with Last Observation Carried Forward (LOCF) imputation technique

Outcome measures

Outcome measures
Measure	Cetrorelix 78 mg n=528 Participants Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
IPSS Change From Baseline	-5.6 Units on a scale Standard Deviation 7.1

Adverse Events

Cetrorelix 78 mg

Serious events: 12 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cetrorelix 78 mg n=528 participants at risk Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
Infections and infestations appendicitis	0.19% 1/528
Psychiatric disorders substance abuse	0.19% 1/528
Vascular disorders hemorrhagic stroke	0.19% 1/528
Cardiac disorders chest pain	0.19% 1/528
Cardiac disorders coronary artery disease	0.19% 1/528
Infections and infestations rectal abcess	0.19% 1/528
Injury, poisoning and procedural complications humerus fracture	0.19% 1/528
Neoplasms benign, malignant and unspecified (incl cysts and polyps) bladder transitional cell carcinoma	0.19% 1/528
Cardiac disorders chest discomfort	0.19% 1/528
Cardiac disorders chest pain / elevated cardiac enzymes	0.19% 1/528
Vascular disorders peripheral artery anuerysm / aortic aneurysm	0.19% 1/528
Gastrointestinal disorders small intestinal obstruction	0.19% 1/528

Other adverse events

Other adverse events
Measure	Cetrorelix 78 mg n=528 participants at risk Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.
Vascular disorders Hot flush	9.3% 49/528

Additional Information

Daniel Croteau, Medical Manager

AEterna Zentaris

Phone: 418-652-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60