Abstract | OBJECTIVE: METHODS: Double-blind, randomized, multicenter study was undertaken among patients with International Prostate Symptom Score (IPSS) ≥ 13. After a single-blind placebo run-in phase of 4 weeks, treatment was administered at 2-week intervals as follows: 30 + 30 mg, 30 + 30 + 30 mg, 60 + 30, 60 + 60 mg cetrorelix pamoate, or matching placebo. Patients were followed-up for 28 weeks after randomization. RESULTS: A statistically significant overall difference was found with respect to the primary variable, the IPSS (P ≤ .001). Optimal results, a 4-point improvement in IPSS in excess of the changes observed in the placebo group, were achieved with a starting dose of 60 mg cetrorelix pamoate followed by a dose of 30 mg 2 weeks later. In all dosage groups, the symptomatic improvement was paralleled by an increase in uroflow. There was a marked dissociation between only moderate and transient testosterone suppression and the persisting effects on BPH signs and symptoms. Tolerability was good at all cetrorelix dosages. CONCLUSIONS:
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Authors | Frans Debruyne, Mitko Tzvetkov, Silvio Altarac, Petrisor A Geavlete |
Journal | Urology
(Urology)
Vol. 76
Issue 4
Pg. 927-33
(Oct 2010)
ISSN: 1527-9995 [Electronic] United States |
PMID | 20932411
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2010. Published by Elsevier Inc. |
Chemical References |
- Delayed-Action Preparations
- Hormone Antagonists
- Receptors, LHRH
- Gonadotropin-Releasing Hormone
- Testosterone
- cetrorelix
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Topics |
- Aged
- Aged, 80 and over
- Delayed-Action Preparations
- Dose-Response Relationship, Drug
- Double-Blind Method
- Erectile Dysfunction
(chemically induced)
- Gonadotropin-Releasing Hormone
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Hormone Antagonists
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Injections, Intramuscular
- Male
- Middle Aged
- Prostatic Hyperplasia
(blood, complications, drug therapy)
- Quality of Life
- Receptors, LHRH
(antagonists & inhibitors)
- Severity of Illness Index
- Single-Blind Method
- Testosterone
(blood)
- Urination Disorders
(etiology)
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