Fernand Labrie1, David F Archer2, Céline Bouchard3, Ginette Girard4, Normand Ayotte5, John C Gallagher6, Leonello Cusan7, Mira Baron8, François Blouin9, Arthur S Waldbaum10, William Koltun11, David J Portman12, Isabelle Côté2, Lyne Lavoie2, Adam Beauregard2, Claude Labrie2, Céline Martel2, John Balser13, Érick Moyneur14. 1. EndoCeutics Inc., Quebec City, QC, Canada. Electronic address: Fernand.Labrie@endoceutics.com. 2. Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA, USA. 3. Clinique de Recherche en Santé des Femmes, Quebec City, QC, Canada. 4. Diex Recherche Inc., Sherbrooke, QC, Canada. 5. Clinique de Gynécologie, Shawinigan, QC, Canada. 6. Creighton University Medical Center, Omaha, NE, USA. 7. Clinique de Recherche en Traitements Hormonaux, Quebec City, QC, Canada. 8. Rapid Medical Research Inc., Cleveland, OH, USA. 9. Pro-Recherche, St-Romuald, QC, Canada. 10. Downtown Women's Health Care, Denver, CO, USA. 11. Medical Center for Clinical Research, San Diego, CA, USA. 12. Columbus Center for Women's Health Research, Columbus, OH, USA. 13. Veristat, Holliston, MA, USA. 14. StatLog Consulting Inc., Ottawa, ON, Canada.
Abstract
OBJECTIVE: An objective was to analyze the time course of efficacy of daily intravaginal administration of 0.5% (6.5mg) 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).
OBJECTIVE: An objective was to analyze the time course of efficacy of daily intravaginal administration of 0.5% (6.5mg) 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).
Authors: Crystal S Denlinger; Tara Sanft; K Scott Baker; Shrujal Baxi; Gregory Broderick; Wendy Demark-Wahnefried; Debra L Friedman; Mindy Goldman; Melissa Hudson; Nazanin Khakpour; Allison King; Divya Koura; Elizabeth Kvale; Robin M Lally; Terry S Langbaum; Michelle Melisko; Jose G Montoya; Kathi Mooney; Javid J Moslehi; Tracey O'Connor; Linda Overholser; Electra D Paskett; Jeffrey Peppercorn; M Alma Rodriguez; Kathryn J Ruddy; Paula Silverman; Sophia Smith; Karen L Syrjala; Amye Tevaarwerk; Susan G Urba; Mark T Wakabayashi; Phyllis Zee; Deborah A Freedman-Cass; Nicole R McMillian Journal: J Natl Compr Canc Netw Date: 2017-09 Impact factor: 11.908