XXXX for hot flushes induced by a gonadotropin-releasing hormone agonist: a controlled study.

@entity1 @entity4545 @entity4089 @entity40131 @entity5759 @entity1176 @entity931 @entity1868
OBJECTIVES: To evaluate the efficacy of @entity40131 , a @entity5759 derivative, in the treatment of hot flushes induced by @entity1176 agonists ( @entity1176 -a) and to study peripheral blood mononuclear cell @entity4545 concentrations during drug administration. DESIGN: Randomized, placebo-controlled, double-blind trial. SETTING: Academic department of obstetrics and gynecology. @entity1 : Forty @entity1 of mean age 43 +/- 5 years who experienced disturbing hot flushes during a 4-month course of tryptorelin depot for @entity1868 -associated @entity931 . INTERVENTIONS: Treatment with oral @entity40131 100 mg/d (20 subjects) or matching placebo (20 subjects) during the third month of @entity1176 -a administration. MAIN OUTCOME MEASURES: Modifications of frequency and severity of hot flushes as shown by a 0 to 6-point vasomotor scoring system and variations of @entity4545 levels in peripheral blood mononuclear cells. RESULTS: Two subjects in each group dropped out of the study. The median (range) vasomotor score at the end of the second month of treatment was 4 (3 to 6) in both the @entity40131 and placebo group. At the end of the third and fourth months the median (range) scores were, respectively, 2 (0 to 6) versus 4 (1 to 6) and 2 (0 to 5) versus 4 (1 to 6). No significant variations in mononuclear cell @entity4545 concentrations were recorded. Serum PRL levels rose from 11.7 +/- 5.7 to 132.3 +/- 65.0 ng/mL (conversion factor to SI unit, 1.0) during @entity40131 administration and returned to 10.6 +/- 3.7 ng/mL after drug withdrawal. CONCLUSION: @entity40131 reduced vasomotor symptoms induced by a @entity1176 -a. Transient @entity4089 was the main side effect observed. The mode of action of the drug in @entity1176 -a-treated @entity1 and possible interactions with endogenous opioid peptides need further elucidation.
