What is the VeLVET Study? The VeLVET STUDY will compare the benefits of MonaLisa vaginal laser therapy and vaginal estrogen therapy on vaginal dryness and other symptoms related to genitourinary syndrome of menopause (GSM). Vaginal estrogen (Premarin® cream, ESTRACE® cream or Vagifem® tablets) therapy has been shown to be effective in treating GSM and is considered “standard of care” for those women who do not have contraindications to vaginal estrogen.
Why is this study important? The MonaLisa vaginal laser is FDA approved for use to treat gynecologic conditions. Recently, it has been used to treat GSM with satisfactory outcomes. Researchers are trying to determine if MonaLisa vaginal laser therapy is more effective than vaginal estrogen therapy.
Contact InformationFor more information If you would like more information about the VeLVET Study or if you are interested in participating, please call Women & Infants’ Division of Urogynecology and Reconstructive Pelvic Surgery research line, at (401) 274-1122, ext. 48221.
What will I be asked to do?
- If you are eligible, you will be randomly assigned, like the flip of a coin, to receive either vaginal laser treatment or vaginal estrogen therapy.
- If you are randomized to the laser arm, you will undergo laser therapy at the beginning of the study, and again at your six-week and three-month visits.
- If you are randomized to the vaginal estrogen arm, you will be prescribed and asked to administer one of three common choices of vaginal estrogen therapy based on preference of cream or tablet form.
- You will also be asked to complete a series of questionnaires to evaluate pain, your GSM condition, and urinary and sexual function throughout the study.
What will the study cost me? Some of the services you will receive during this research study are considered to be routine care that you would have received even if you were not participating in the research study.
If you are randomized to the vaginal laser therapy treatments (three in total), these treatments and their visits will be provided as part of the study at no cost to you.
If you are randomized to the vaginal estrogen arm, all of your visits as well as the vaginal estrogen therapy are considered routine care and will be billed to your insurance. You are responsible for paying any deductibles, co-payments or co-insurance. You will be provided $100 per month for your participation in the study after completing each visit for a total of $300 to help offset the costs of the medication.
What happens to the information collected about me? All research information will be treated confidentially. All of your study forms will be assigned a number, not your name.
Can I drop out of the study once I have begun? Participation in the study is completely voluntary, and you may remove yourself from the study at any point. If you decide to drop out of the study, medical care will continue to be provided to you if you would like.
Women & Infants