Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy

52-week open-label study

Fernand Labrie, David F. Archer, Céline Bouchard, Ginette Girard, Normand Ayotte, John Christopher G. Gallagher, Leonello Cusan, Mira Baron, François Blouin, Arthur S. Waldbaum, William Koltun, David J. Portman, Isabelle Côté, Lyne Lavoie, Adam Beauregard, Claude Labrie, Céline Martel, John Balser, Érick Moyneur

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Objective An objective was to analyze the time course of efficacy of daily intravaginal administration of 0.5% (6.5 mg) DHEA (prasterone) for 52 weeks on the moderate to severe (MS) symptoms and signs of vulvovaginal atrophy (VVA). Method Five hundred twenty-one postmenopausal women were enrolled and received daily intravaginal administration of 0.5% DHEA in an open-label phase III study. The severity of the VVA symptoms examined in detail in the different groups. Results A parallel improvement of pain at sexual activity was observed in women who had moderate to severe (MS) dyspareunia as their most bothersome symptom (MBS) (n = 183) or not MBS (n = 240) and MS without being MBS (n = 57) with a 1.70 severity unit change in the MBS group for a decrease of 66.1% from baseline (p <0.0001 versus baseline) over 52 weeks. A further improvement of dyspareunia, namely 0.33 severity unit (19.4%), was observed with continuing treatment from 12 weeks to 52 weeks. Similar results were observed on vaginal dryness and irritation/itching. Highly significant beneficial effects (p <0.0001 versus baseline for all) were observed at gynecological examination on vaginal secretions, color, epithelial integrity and epithelial surface thickness. Conclusion The present study shows, in addition to the parallel benefits on the three symptoms of VVA, that the choice of any of the MS symptoms as being or not being MBS by women has no influence on the observed therapeutic effect (NCT01256671).

Original languageEnglish
Pages (from-to)46-56
Number of pages11
JournalMaturitas
Volume81
Issue number1
DOIs
StatePublished - May 1 2015

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Dehydroepiandrosterone
Intravaginal Administration
Atrophy
Dyspareunia
Labels
Gynecological Examination
Therapeutic Uses
Pruritus
Sexual Behavior
Signs and Symptoms
Color
Pain
Therapeutics

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy : 52-week open-label study. / Labrie, Fernand; Archer, David F.; Bouchard, Céline; Girard, Ginette; Ayotte, Normand; Gallagher, John Christopher G.; Cusan, Leonello; Baron, Mira; Blouin, François; Waldbaum, Arthur S.; Koltun, William; Portman, David J.; Côté, Isabelle; Lavoie, Lyne; Beauregard, Adam; Labrie, Claude; Martel, Céline; Balser, John; Moyneur, Érick.

In: Maturitas, Vol. 81, No. 1, 01.05.2015, p. 46-56.

Research output: Contribution to journalArticle

Labrie, F, Archer, DF, Bouchard, C, Girard, G, Ayotte, N, Gallagher, JCG, Cusan, L, Baron, M, Blouin, F, Waldbaum, AS, Koltun, W, Portman, DJ, Côté, I, Lavoie, L, Beauregard, A, Labrie, C, Martel, C, Balser, J & Moyneur, É 2015, 'Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study', Maturitas, vol. 81, no. 1, pp. 46-56. https://doi.org/10.1016/j.maturitas.2015.02.005
Labrie, Fernand ; Archer, David F. ; Bouchard, Céline ; Girard, Ginette ; Ayotte, Normand ; Gallagher, John Christopher G. ; Cusan, Leonello ; Baron, Mira ; Blouin, François ; Waldbaum, Arthur S. ; Koltun, William ; Portman, David J. ; Côté, Isabelle ; Lavoie, Lyne ; Beauregard, Adam ; Labrie, Claude ; Martel, Céline ; Balser, John ; Moyneur, Érick. / Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy : 52-week open-label study. In: Maturitas. 2015 ; Vol. 81, No. 1. pp. 46-56.
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abstract = "Objective An objective was to analyze the time course of efficacy of daily intravaginal administration of 0.5{\%} (6.5 mg) DHEA (prasterone) for 52 weeks on the moderate to severe (MS) symptoms and signs of vulvovaginal atrophy (VVA). Method Five hundred twenty-one postmenopausal women were enrolled and received daily intravaginal administration of 0.5{\%} DHEA in an open-label phase III study. The severity of the VVA symptoms examined in detail in the different groups. Results A parallel improvement of pain at sexual activity was observed in women who had moderate to severe (MS) dyspareunia as their most bothersome symptom (MBS) (n = 183) or not MBS (n = 240) and MS without being MBS (n = 57) with a 1.70 severity unit change in the MBS group for a decrease of 66.1{\%} from baseline (p <0.0001 versus baseline) over 52 weeks. A further improvement of dyspareunia, namely 0.33 severity unit (19.4{\%}), was observed with continuing treatment from 12 weeks to 52 weeks. Similar results were observed on vaginal dryness and irritation/itching. Highly significant beneficial effects (p <0.0001 versus baseline for all) were observed at gynecological examination on vaginal secretions, color, epithelial integrity and epithelial surface thickness. Conclusion The present study shows, in addition to the parallel benefits on the three symptoms of VVA, that the choice of any of the MS symptoms as being or not being MBS by women has no influence on the observed therapeutic effect (NCT01256671).",
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T1 - Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy

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AU - Labrie, Fernand

AU - Archer, David F.

AU - Bouchard, Céline

AU - Girard, Ginette

AU - Ayotte, Normand

AU - Gallagher, John Christopher G.

AU - Cusan, Leonello

AU - Baron, Mira

AU - Blouin, François

AU - Waldbaum, Arthur S.

AU - Koltun, William

AU - Portman, David J.

AU - Côté, Isabelle

AU - Lavoie, Lyne

AU - Beauregard, Adam

AU - Labrie, Claude

AU - Martel, Céline

AU - Balser, John

AU - Moyneur, Érick

PY - 2015/5/1

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N2 - Objective An objective was to analyze the time course of efficacy of daily intravaginal administration of 0.5% (6.5 mg) DHEA (prasterone) for 52 weeks on the moderate to severe (MS) symptoms and signs of vulvovaginal atrophy (VVA). Method Five hundred twenty-one postmenopausal women were enrolled and received daily intravaginal administration of 0.5% DHEA in an open-label phase III study. The severity of the VVA symptoms examined in detail in the different groups. Results A parallel improvement of pain at sexual activity was observed in women who had moderate to severe (MS) dyspareunia as their most bothersome symptom (MBS) (n = 183) or not MBS (n = 240) and MS without being MBS (n = 57) with a 1.70 severity unit change in the MBS group for a decrease of 66.1% from baseline (p <0.0001 versus baseline) over 52 weeks. A further improvement of dyspareunia, namely 0.33 severity unit (19.4%), was observed with continuing treatment from 12 weeks to 52 weeks. Similar results were observed on vaginal dryness and irritation/itching. Highly significant beneficial effects (p <0.0001 versus baseline for all) were observed at gynecological examination on vaginal secretions, color, epithelial integrity and epithelial surface thickness. Conclusion The present study shows, in addition to the parallel benefits on the three symptoms of VVA, that the choice of any of the MS symptoms as being or not being MBS by women has no influence on the observed therapeutic effect (NCT01256671).

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