A Clinical Study of Intravaginal Prasterone (Intrarosa®) in Postmenopausal Vulvovaginal Atrophy

Postmenopausal Vulvovaginal Atrophy Clinical Trial

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase Ⅲ, Efficacy and Safety Study of Intravaginal Prasterone (INTRAROSA) on Postmenopausal Vulvovaginal Atrophy (VVA)

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

The phase 1 study which includes the screening phase (up to 3 weeks) and treatment phase (12 weeks). After signing the informed consent, the inclusion and exclusion criteria will be confirmed preliminarily at screening visit and reconfirmed at Day 1 (baseline). At least 418 eligible subjects will be randomized in a 1:1 ratio to receive 6.5mg of intravaginal prasterone or placebo once-daily for 12 weeks. The phase 2 study which includes the treatment phase (26 weeks). A total of 100 subjects who have completed Phase 1, not occur adverse event（AE） grade ≥3 or serious adverse event (SAE), or recover all AE grades ≤1, and voluntary to participate in Phase 2 study. After signing the ICF, the subject will receive 6.5mg of intravaginal for 26 weeks. ;

Related Conditions & MeSH terms

• Atrophy
• Postmenopausal Vulvovaginal Atrophy

• NCT number: NCT04982692
• Study type: Interventional
• Source: Lee's Pharmaceutical Limited
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 13, 2021
• Completion date: March 30, 2023