title: Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator.
abstract: The objective of the study is to evaluate the acceptability of the intravaginal administration of ovules/suppositories of DHEA (dehydroepiandrosterone, prasterone) for the treatment of vulvovaginal atrophy (VVA) in women with moderate to severe dyspareunia who were administered daily for 12 weeks intravaginal 0.50% (6.5 mg) DHEA or placebo. There were a total of 373 women in the per-protocol population who responded to the questionnaire for both treatment groups. While it was planned that the applicator would be evaluated as suitable if at least 80% of participants have a global score  ≤ 2 units, 99% and 100% of participants had a score  ≤ 2 units in the placebo and DHEA groups, respectively, for the global score (mean of 5 questions). When asked about like and dislike the technique of drug administration, 284 comments were positive, while 114 women gave no comment. About 92-94% of women indicated that they were very confident to be able use the applicator successfully in the future. The survey shows a high degree of satisfaction and of confidence to use the applicator successfully in the future.
authors.affiliation: a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada .
authors.forename: Marlene
authors.initials: M
authors.lastname: Montesino
authors.affiliation: a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada .
authors.forename: Fernand
authors.initials: F
authors.lastname: Labrie
authors.affiliation: b Clinical Research Center, Eastern Virginia Medical School , Norfolk , VA , USA .
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
authors.affiliation: a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada .
authors.forename: Jaâfar
authors.initials: J
authors.lastname: Zerhouni
authors.affiliation: a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada .
authors.forename: Isabelle
authors.initials: I
authors.lastname: Côté
authors.affiliation: a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada .
authors.forename: Lyne
authors.initials: L
authors.lastname: Lavoie
authors.affiliation: a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada .
authors.forename: Adam
authors.initials: A
authors.lastname: Beauregard
authors.affiliation: a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada .
authors.forename: Céline
authors.initials: C
authors.lastname: Martel
authors.affiliation: a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada .
authors.forename: Mario
authors.initials: M
authors.lastname: Vaillancourt
authors.affiliation: c StatLog Consulting Inc , Ottawa , ON , Canada , and.
authors.forename: Erick
authors.initials: E
authors.lastname: Moyneur
authors.affiliation: d Veristat Inc. , Holliston , MA , USA.
authors.forename: John
authors.initials: J
authors.lastname: Balser
mesh_terms: D000282:Administration, Intravaginal; D001284:Atrophy / Q000188:drug therapy; D003687:Dehydroepiandrosterone / Q000008:administration & dosage*; D004311:Double-Blind Method; D004414:Dyspareunia / Q000188:drug therapy*; D005260:Female; D006801:Humans; D010342:Patient Acceptance of Health Care; D011446:Prospective Studies; D014621:Vagina / Q000473:pathology; D014623:Vaginal Diseases / Q000188:drug therapy*
chemical_list: D003687:Dehydroepiandrosterone
keywords: Dyspareunia; prasterone; vaginal applicator; vaginal dryness; vulvovaginal atrophy