Conditions: Vaginal Atrophy
Keywords: Vulvovaginal atrophy (VVA) Vaginal atrophy Atrophic vaginitis prasterone DHEA Intrarosa
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 558
Healthy volunteers: no

Brief summary:
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.

Detailed description:

Arms:
arm 1: Placebo vaginal ovule daily for 12 weeks arm 2: Prasterone (DHEA) vaginal ovule daily for 12 weeks

Interventions: intervention 1: Placebo intervention 2: Prasterone (DHEA)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: