Abstract
Objectives: To evaluate the efficacy of veralipride, a benzamide derivative, in the treatment of hot flushes induced by GnRH agonists (GnRH- a) and to study peripheral blood mononuclear cell β-endorphin concentrations during drug administration. Design: Randomized, placebo-controlled, double- blind trial. Setting: Academic department of obstetrics and gynecology. Patients: Forty women of mean age 43 ± 5 years who experienced disturbing hot flushes during a 4-month course of tryptorelin depot for myoma-associated menorrhagia. Interventions: Treatment with oral veralipride 100 mg/d (20 subjects) or matching placebo (20 subjects) during the third month of GnRH-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 β-endorphin 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 veralipride 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 β-endorphin 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 veralipride administration and returned to 10.6 ± 3.7 ng/mL after drug withdrawal. Conclusion: Veralipride reduced vasomotor symptoms induced by a GnRH-a. Transient hyperprolactinemia was the main side effect observed. The mode of action of the drug in GnRH-a-treated patients and possible interactions with endogenous opioid peptides need further elucidation.
| Original language | English |
|---|---|
| Pages (from-to) | 938-942 |
| Number of pages | 5 |
| Journal | Fertility and Sterility |
| Volume | 62 |
| Issue number | 5 |
| Publication status | Published - 1994 |
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Keywords
- β- endorphin
- gonadotropin-releasing hormone agonists
- Hot flushes
- veralipride
ASJC Scopus subject areas
- Obstetrics and Gynaecology
Cite this
Veralipride for hot flushes induced by a gonadotropin-releasing hormone agonist : A controlled study. / Vercellini, P.; Sacerdote, P.; Trespidi, L.; Manfredi, B.; Panerai, A. E.; Crosignani, P. G.
In: Fertility and Sterility, Vol. 62, No. 5, 1994, p. 938-942.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Veralipride for hot flushes induced by a gonadotropin-releasing hormone agonist
T2 - A controlled study
AU - Vercellini, P.
AU - Sacerdote, P.
AU - Trespidi, L.
AU - Manfredi, B.
AU - Panerai, A. E.
AU - Crosignani, P. G.
PY - 1994
Y1 - 1994
N2 - Objectives: To evaluate the efficacy of veralipride, a benzamide derivative, in the treatment of hot flushes induced by GnRH agonists (GnRH- a) and to study peripheral blood mononuclear cell β-endorphin concentrations during drug administration. Design: Randomized, placebo-controlled, double- blind trial. Setting: Academic department of obstetrics and gynecology. Patients: Forty women of mean age 43 ± 5 years who experienced disturbing hot flushes during a 4-month course of tryptorelin depot for myoma-associated menorrhagia. Interventions: Treatment with oral veralipride 100 mg/d (20 subjects) or matching placebo (20 subjects) during the third month of GnRH-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 β-endorphin 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 veralipride 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 β-endorphin 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 veralipride administration and returned to 10.6 ± 3.7 ng/mL after drug withdrawal. Conclusion: Veralipride reduced vasomotor symptoms induced by a GnRH-a. Transient hyperprolactinemia was the main side effect observed. The mode of action of the drug in GnRH-a-treated patients and possible interactions with endogenous opioid peptides need further elucidation.
AB - Objectives: To evaluate the efficacy of veralipride, a benzamide derivative, in the treatment of hot flushes induced by GnRH agonists (GnRH- a) and to study peripheral blood mononuclear cell β-endorphin concentrations during drug administration. Design: Randomized, placebo-controlled, double- blind trial. Setting: Academic department of obstetrics and gynecology. Patients: Forty women of mean age 43 ± 5 years who experienced disturbing hot flushes during a 4-month course of tryptorelin depot for myoma-associated menorrhagia. Interventions: Treatment with oral veralipride 100 mg/d (20 subjects) or matching placebo (20 subjects) during the third month of GnRH-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 β-endorphin 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 veralipride 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 β-endorphin 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 veralipride administration and returned to 10.6 ± 3.7 ng/mL after drug withdrawal. Conclusion: Veralipride reduced vasomotor symptoms induced by a GnRH-a. Transient hyperprolactinemia was the main side effect observed. The mode of action of the drug in GnRH-a-treated patients and possible interactions with endogenous opioid peptides need further elucidation.
KW - β- endorphin
KW - gonadotropin-releasing hormone agonists
KW - Hot flushes
KW - veralipride
UR - http://www.scopus.com/inward/record.url?scp=0027944088&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0027944088&partnerID=8YFLogxK
M3 - Article
C2 - 7926138
AN - SCOPUS:0027944088
VL - 62
SP - 938
EP - 942
JO - Fertility and Sterility
JF - Fertility and Sterility
SN - 0015-0282
IS - 5
ER -