Dysport in Vulvodynia Phase II Study

PHASE2TerminatedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 11, 2018

Primary Completion Date

January 21, 2021

Study Completion Date

January 21, 2021

Conditions
Vulvodynia
Interventions
BIOLOGICAL

Botulinum toxin type A

Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles.

DRUG

Placebo

The reconstituted solution will be injected intramuscularly across pelvic floor muscles.

Trial Locations (9)

10036

The Center for Vulvovaginal Disorders, New York

20036

James A. Simon, MD, PC, Washington D.C.

20037

The Center for Vulvovaginal Disorders, Washington D.C.

33186

New Age Medical Research Corporation, Miami

37209

Women's Institute for Sexual Health (WISH), Nashville

66160

University of Kansas Medical Center, Kansas City

68130

Omaha OB-GYN Associates, PC, Omaha

98105

Seattle Women's: Health, Research, Gynecology®, Seattle

G15 2L6

Clinique de Santé des Femmes, Québec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY