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A Clinical Study of INTRAROSA® (Prasterone) Vaginal Inserts in Postmenopausal Vulvovaginal Atrophy

NCT04982692 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 417

Last updated 2024-10-18

No results posted yet for this study

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.

Conditions

  • Postmenopausal Vulvovaginal Atrophy

Interventions

DRUG

intravaginal prasterone

6.5 mg of Intravaginal prasterone once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks.

DRUG

Placebo ovules

Placebo ovules once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks.

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Principal Investigators

  • long Sui · No. 419, Fangxie Road, Huangpu District, Shanghai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2023-01-30
Completion
2023-05-08

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982692 on ClinicalTrials.gov