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Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy
Recruiting
I'm InterestedTrial ID: NCT02691936
Purpose
This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2
fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of
vulvovaginal atrophy/GSM.
Official Title
A Randomized Clinical Trial Comparing Vaginal Laser Therapy to Vaginal Estrogen Therapy in Women With Genitourinary Syndrome of Menopause
Stanford Investigator(s)
Eric R. Sokol, MD
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology
Eligibility
Inclusion Criteria:
- Menopausal with absence of menstruation for at least 12 months
- Presence of vaginal atrophy symptoms [subjective assessment of vaginal dryness >7cm on
VAS)
- Prolapse stage < II, according to the pelvic organ prolapse quantification (POP-Q)
system[31]
- No pelvic surgery within 6 months prior to treatment (vulva biopsy may be included
after 2 weeks)
- Understanding and acceptance of the obligation to return for all scheduled follow-up
visits
Exclusion Criteria:
- Personal history of vulvovaginal condyloma,,vaginal intraepithelial neoplasia (VAIN),
vaginal carcinoma, lichen sclerosis, lichen planus, history of vaginal radiation,
history of cervical cancer, other gynecologic cancer, or pelvic radiation
- Acute or recurrent urinary tract infection (UTI), or genital infection (e.g.
bacterial; vaginosis, herpes genitalis, candida).
- Personal history of Scleroderma
- Any serious disease, or chronic condition, that could interfere with the study
compliance
- Previously undergone reconstructive pelvic surgery within the past 6 months
- Previously undergone reconstructive pelvic surgery with transvaginal mesh kits and
sacrocolpopexy with synthetic mesh for prolapse, excluding synthetic slings (unless
current untreated exposure or extrusion)
- Have used vaginal estrogen cream, ring or tablet within 1 month prior to entering the
study
- Vaginal moisturizers, lubricants or homeopathic preparations within 2 weeks of therapy
- Personal history of thrombophlebitis
- Personal history of heart failure or myocardial infarction within 12 months of
procedure
- Use or anticipated use of antiplatelet therapy, anticoagulants, thrombolytics, vitamin
E or nonsteroidal anti-inflammatory drugs within 2 weeks pre-treatment
- Taking medications that are photosensitive
- Contraindication to Vaginal Estrogen Therapy
- Unwilling to Take Vaginal Estrogen
- Inability to give informed consent
Intervention(s):
device: CO2 fractionated vaginal laser
drug: Estrogens, Conjugated (USP)
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Eric Sokol, M.D.