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

PHASE3CompletedINTERVENTIONAL
Enrollment

417

Participants

Timeline

Start Date

September 13, 2021

Primary Completion Date

January 30, 2023

Study Completion Date

May 8, 2023

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.

Trial Locations (1)

Unknown

Obstetrics and Gynecology Hospital of Fudan University, Shanghai

Sponsors
All Listed Sponsors
lead

Lee's Pharmaceutical Limited

INDUSTRY