VeLVET Study: Randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy
If you would like more information about the VeLVET Study or if you are interested in participating, please call The Cleveland Clinic Department of Ob/Gyn and Women’s Health Institute research line, at 216-445-8090.
What is the VeLVET Study?
The VeLVET STUDY will compare the effects of vaginal laser therapy and vaginal estrogen therapy on the symptoms related to GSM and the condition of vaginal health. 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.
Who is eligible to participate in this study?
You may be eligible to participate in this study if you:
- have not had a menstrual cycle for at least 12 months;
- have presence of vaginal dryness;
- have not had pelvic surgery within 6-months prior to treatment; and
- understand and accept the obligation to return for all scheduled follow-up visits.
Why is this study important?
The purpose of this study is to compare the effects of vaginal laser therapy and vaginal estrogen therapy on the symptoms related to GSM and the condition of vaginal health. The MonaLisa vaginal laser is FDA approved for use to treat gynecologic conditions. Recently, it has been used to treat GSM with satisfactory outcomes.
What will I be asked to do?
- If you are eligible, you will be randomly assigned, like the flip of a coin, to either receive either vaginal laser treatment or vaginal estrogen therapy
- If you are randomized to the laser arm, you will undergo laser therapy at the Baseline, 6-Week and 3-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.
- In addition, you will also complete a series of questionnaires to evaluate pain, your GSM condition, urinary and sexual function throughout the study.
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.
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 (3 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 therapy, all of your visits as well as the estrogen therapy are considered routine care and will be billed to your insurance. You are responsible for paying any deductibles, copayments or co-insurance. You will be provided $100 per month for your participation in the study when you complete the Baseline, 6-Week and 3-Month visits for a total of $300 to help off-set the costs of the medication.