CO2 Laser vs Lidocaine for Vestibulodynia in Premenopausal Women
Completed · Not applicable
Conditions studied: Vulvodynia
In brief
CO2 laser energy is currently used widely for the treatment of postmenopausal women who have vaginal atrophy due to the lack of estrogen. However, its effect on premenopausal women with hormonally-mediated vulvar vestibulodynia is unknown. This study seeks to evaluate the effect of CO2 laser on young women and compare it to topical lidocaine.
Key facts
- Study ID
- NCT05336825
- Run by
- Atlantic Health System
- People needed
- 10
- Starts
- 2019-04-01
- Expected to finish
- 2021-01-31
- Last updated by the study team
- 2022-04-20
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Age 18 years to 40 years
- Hormonal contraceptive therapy for at least one year consecutive duration
- Vestibulodynia diagnosis meeting the following criteria:
- Localized vulvar pain to vaginal vestibule
- At least 3 months duration
- Without clear identifiable cause
You may not qualify if…
- Suspected primary cause to vestibular pain that warrants directed treatment
- History of chronic infection or autoimmune disease
- Prior pelvic surgery including mesh placement for incontinence or prolapse, vestibulectomy, vulvectomy, or labiaplasty
- Active vulvar or vaginal infection
- Allergy or contraindication to topical lidocaine treatment
- Prior diagnosis or treatment of vulvar intraepithelial neoplasia or vulvar malignancy
Where it is running
- Garden State Urology — Denville, New Jersey, United States
Full record on ClinicalTrials.gov
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