Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy

Completed · Not applicable

Conditions studied: Atrophic Vaginitis, Menopause

In brief

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.

Key facts

Study ID

NCT02691936

Run by

The Cleveland Clinic

People needed

69

Starts

2016-03-01

Expected to finish

2018-12-01

Last updated by the study team

2019-10-30

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Christ Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Brown Medical School — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.