A Clinical Study of Intravaginal Prasterone (Intrarosa®) in Postmenopausal Vulvovaginal Atrophy
Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
This study is a phase III which includes two treatment phases. The phase 1 study is a
multi-center, randomized, double-blind, placebo- controlled, parallel group that provide
primary efficacy and safety data.
The Phase 2 study is a single-arm, open-label conducted in a subset of subjects who completed
the phase 1 study to provid additional long-term safety and efficacy.