| Autor: |
Montesino M; a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada ., Labrie F; a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada ., Archer DF; b Clinical Research Center, Eastern Virginia Medical School , Norfolk , VA , USA ., Zerhouni J; a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada ., Côté I; a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada ., Lavoie L; a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada ., Beauregard A; a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada ., Martel C; a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada ., Vaillancourt M; a EndoCeutics Inc , Quebec City , Quebec, G1V 4M7 , Canada ., Moyneur E; c StatLog Consulting Inc , Ottawa , ON , Canada , and., Balser J; d Veristat Inc. , Holliston , MA , USA. |
| Abstrakt: |
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. |
