Letrozole and norethisterone acetate versus letrozole and triptorelin in the treatment of endometriosis related pain symptoms: A randomized controlled trial

Simone Ferrero, Pier L. Venturini, David J. Gillott, Valentino Remorgida

Research output: Contribution to journalArticle

Abstract

Background: When aromatase inhibitors are used to treat premenopausal women with endometriosis, additional drugs should be used to effectively down-regulate gonadal estrogen biosynthesis. This randomized prospective open-label study compared the efficacy in treating pain symptoms and the tolerability of letrozole combined with either norethisterone acetate or triptorelin.Methods: Women with pain symptoms caused by rectovaginal endometriosis were treated with letrozole (2.5 mg/day) and were randomized to also receive either oral norethisterone acetate (2.5 mg/day; group N) or intramuscular injection of triptorelin (11.25 mg every 3 months; group T). The scheduled length of treatment was 6 months. A visual analogue scale and a multidimensional categorical rating scale were used to assess the severity of pain symptoms. The volume of the endometriotic nodules was estimated by ultrasonography using virtual organ computer-aided analysis. Adverse effects of treatment were recorded.Results: A total of 35 women were randomized between the two treatment protocols. Significantly more patients in group N rated their treatment as satisfactory or very satisfactory (64.7%) as compared to group T (22.2%; p = 0.028). The intensity of both non-menstrual pelvic pain and deep dyspareunia significantly decreased during treatment in both study groups, though no statistically meaningful difference between the two groups was apparent. Reduction in the volume of endometriotic nodules was significantly greater in group T than in group N. Interruption of treatment due to adverse effects significantly differed between the groups, with 8 women in group T (44.4%) and 1 woman in group N (5.9%) interrupting treatment (p = 0.018). Similarly, 14 women included in group T (77.8%) and 6 women included in group N (35.3%) experienced adverse effects of treatment (p = 0.018). During treatment, mineral bone density significantly decreased in group T but not in group N.Conclusions: Aromatase inhibitors reduce the intensity of endometriosis-related pain symptoms. Combining letrozole with oral norethisterone acetate was associated with a lower incidence of adverse effects and a lower discontinuation rate than combining letrozole with triptorelin.

Original languageEnglish
Article number88
JournalReproductive Biology and Endocrinology
Volume9
DOIs
Publication statusPublished - Jun 21 2011

Fingerprint

letrozole
Triptorelin Pamoate
Endometriosis
Randomized Controlled Trials
Pain
Aromatase Inhibitors
Therapeutics
Dyspareunia
Pelvic Pain
norethindrone acetate
Intramuscular Injections
Clinical Protocols
Visual Analog Scale

ASJC Scopus subject areas

  • Developmental Biology
  • Endocrinology
  • Reproductive Medicine
  • Medicine(all)

Cite this

Letrozole and norethisterone acetate versus letrozole and triptorelin in the treatment of endometriosis related pain symptoms : A randomized controlled trial. / Ferrero, Simone; Venturini, Pier L.; Gillott, David J.; Remorgida, Valentino.

In: Reproductive Biology and Endocrinology, Vol. 9, 88, 21.06.2011.

Research output: Contribution to journalArticle

@article{a6040333741c4841b4a1b5402df99fb8,
title = "Letrozole and norethisterone acetate versus letrozole and triptorelin in the treatment of endometriosis related pain symptoms: A randomized controlled trial",
abstract = "Background: When aromatase inhibitors are used to treat premenopausal women with endometriosis, additional drugs should be used to effectively down-regulate gonadal estrogen biosynthesis. This randomized prospective open-label study compared the efficacy in treating pain symptoms and the tolerability of letrozole combined with either norethisterone acetate or triptorelin.Methods: Women with pain symptoms caused by rectovaginal endometriosis were treated with letrozole (2.5 mg/day) and were randomized to also receive either oral norethisterone acetate (2.5 mg/day; group N) or intramuscular injection of triptorelin (11.25 mg every 3 months; group T). The scheduled length of treatment was 6 months. A visual analogue scale and a multidimensional categorical rating scale were used to assess the severity of pain symptoms. The volume of the endometriotic nodules was estimated by ultrasonography using virtual organ computer-aided analysis. Adverse effects of treatment were recorded.Results: A total of 35 women were randomized between the two treatment protocols. Significantly more patients in group N rated their treatment as satisfactory or very satisfactory (64.7{\%}) as compared to group T (22.2{\%}; p = 0.028). The intensity of both non-menstrual pelvic pain and deep dyspareunia significantly decreased during treatment in both study groups, though no statistically meaningful difference between the two groups was apparent. Reduction in the volume of endometriotic nodules was significantly greater in group T than in group N. Interruption of treatment due to adverse effects significantly differed between the groups, with 8 women in group T (44.4{\%}) and 1 woman in group N (5.9{\%}) interrupting treatment (p = 0.018). Similarly, 14 women included in group T (77.8{\%}) and 6 women included in group N (35.3{\%}) experienced adverse effects of treatment (p = 0.018). During treatment, mineral bone density significantly decreased in group T but not in group N.Conclusions: Aromatase inhibitors reduce the intensity of endometriosis-related pain symptoms. Combining letrozole with oral norethisterone acetate was associated with a lower incidence of adverse effects and a lower discontinuation rate than combining letrozole with triptorelin.",
author = "Simone Ferrero and Venturini, {Pier L.} and Gillott, {David J.} and Valentino Remorgida",
year = "2011",
month = "6",
day = "21",
doi = "10.1186/1477-7827-9-88",
language = "English",
volume = "9",
journal = "Reproductive Biology and Endocrinology",
issn = "1477-7827",
publisher = "BioMed Central",

}

TY - JOUR

T1 - Letrozole and norethisterone acetate versus letrozole and triptorelin in the treatment of endometriosis related pain symptoms

T2 - A randomized controlled trial

AU - Ferrero, Simone

AU - Venturini, Pier L.

AU - Gillott, David J.

AU - Remorgida, Valentino

PY - 2011/6/21

Y1 - 2011/6/21

N2 - Background: When aromatase inhibitors are used to treat premenopausal women with endometriosis, additional drugs should be used to effectively down-regulate gonadal estrogen biosynthesis. This randomized prospective open-label study compared the efficacy in treating pain symptoms and the tolerability of letrozole combined with either norethisterone acetate or triptorelin.Methods: Women with pain symptoms caused by rectovaginal endometriosis were treated with letrozole (2.5 mg/day) and were randomized to also receive either oral norethisterone acetate (2.5 mg/day; group N) or intramuscular injection of triptorelin (11.25 mg every 3 months; group T). The scheduled length of treatment was 6 months. A visual analogue scale and a multidimensional categorical rating scale were used to assess the severity of pain symptoms. The volume of the endometriotic nodules was estimated by ultrasonography using virtual organ computer-aided analysis. Adverse effects of treatment were recorded.Results: A total of 35 women were randomized between the two treatment protocols. Significantly more patients in group N rated their treatment as satisfactory or very satisfactory (64.7%) as compared to group T (22.2%; p = 0.028). The intensity of both non-menstrual pelvic pain and deep dyspareunia significantly decreased during treatment in both study groups, though no statistically meaningful difference between the two groups was apparent. Reduction in the volume of endometriotic nodules was significantly greater in group T than in group N. Interruption of treatment due to adverse effects significantly differed between the groups, with 8 women in group T (44.4%) and 1 woman in group N (5.9%) interrupting treatment (p = 0.018). Similarly, 14 women included in group T (77.8%) and 6 women included in group N (35.3%) experienced adverse effects of treatment (p = 0.018). During treatment, mineral bone density significantly decreased in group T but not in group N.Conclusions: Aromatase inhibitors reduce the intensity of endometriosis-related pain symptoms. Combining letrozole with oral norethisterone acetate was associated with a lower incidence of adverse effects and a lower discontinuation rate than combining letrozole with triptorelin.

AB - Background: When aromatase inhibitors are used to treat premenopausal women with endometriosis, additional drugs should be used to effectively down-regulate gonadal estrogen biosynthesis. This randomized prospective open-label study compared the efficacy in treating pain symptoms and the tolerability of letrozole combined with either norethisterone acetate or triptorelin.Methods: Women with pain symptoms caused by rectovaginal endometriosis were treated with letrozole (2.5 mg/day) and were randomized to also receive either oral norethisterone acetate (2.5 mg/day; group N) or intramuscular injection of triptorelin (11.25 mg every 3 months; group T). The scheduled length of treatment was 6 months. A visual analogue scale and a multidimensional categorical rating scale were used to assess the severity of pain symptoms. The volume of the endometriotic nodules was estimated by ultrasonography using virtual organ computer-aided analysis. Adverse effects of treatment were recorded.Results: A total of 35 women were randomized between the two treatment protocols. Significantly more patients in group N rated their treatment as satisfactory or very satisfactory (64.7%) as compared to group T (22.2%; p = 0.028). The intensity of both non-menstrual pelvic pain and deep dyspareunia significantly decreased during treatment in both study groups, though no statistically meaningful difference between the two groups was apparent. Reduction in the volume of endometriotic nodules was significantly greater in group T than in group N. Interruption of treatment due to adverse effects significantly differed between the groups, with 8 women in group T (44.4%) and 1 woman in group N (5.9%) interrupting treatment (p = 0.018). Similarly, 14 women included in group T (77.8%) and 6 women included in group N (35.3%) experienced adverse effects of treatment (p = 0.018). During treatment, mineral bone density significantly decreased in group T but not in group N.Conclusions: Aromatase inhibitors reduce the intensity of endometriosis-related pain symptoms. Combining letrozole with oral norethisterone acetate was associated with a lower incidence of adverse effects and a lower discontinuation rate than combining letrozole with triptorelin.

UR - http://www.scopus.com/inward/record.url?scp=79959208713&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79959208713&partnerID=8YFLogxK

U2 - 10.1186/1477-7827-9-88

DO - 10.1186/1477-7827-9-88

M3 - Article

C2 - 21693037

AN - SCOPUS:79959208713

VL - 9

JO - Reproductive Biology and Endocrinology

JF - Reproductive Biology and Endocrinology

SN - 1477-7827

M1 - 88

ER -