Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy (VeLVET)
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|ClinicalTrials.gov Identifier: NCT02691936|
Recruitment Status : Completed
First Posted : February 25, 2016
Results First Posted : October 17, 2019
Last Update Posted : October 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrophic Vaginitis Menopause||Device: CO2 fractionated vaginal laser Drug: Estrogens, Conjugated (USP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Clinical Trial Comparing Vaginal Laser Therapy to Vaginal Estrogen Therapy in Women With Genitourinary Syndrome of Menopause|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
Experimental: CO2 fractionated vaginal laser
Postmenopausal women will undergo treatment intravaginally with the fractional microablative CO2 laser system MonaLisa Touch vaginal laser protocol x 3 time points at baseline, 6 weeks and 3 months.
Device: CO2 fractionated vaginal laser
Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
Other Name: MonaLisa Touch
Active Comparator: Estrogens, Conjugated (USP)
The women in the vaginal estrogen group will be prescribed and asked to administer the conjugated estrogen cream 0.5 g of cream equivalent to 0.625 mg of conjugated estrogen.
Drug: Estrogens, Conjugated (USP)
Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
Other Name: Vaginal Estrogen cream
- Vaginal Dryness [ Time Frame: 6 months ]Vaginal dryness was assessed using a score of 0 (minimum) and 10 (maximum) on a Visual Analog Scale (VAS). Data presented is the mean difference before and after treatment. A higher mean difference signifies that the vaginal dryness score decreased to a greater measure hence resulting in a better outcome.
- Objective Evaluation of Vaginal Atrophy/Estrogenization [ Time Frame: 6 months ]Vaginal health index (VHI) score is measured on a scale of 0 (minimum) to 5 (maximum) and higher scores means a better outcome.
- Effect of GMS Symptoms on Quality of Life [ Time Frame: 6 months ]DIVA scores are based on a scale of 0 (minimum) to 20 (maximum) with higher scores representing worse outcomes. The data presented are mean differences before and after treatment.
- Effect of Treatment on Vaginal Maturation Index [ Time Frame: 6 months ]Vaginal Maturity Index (VMI) scores are from 0 (minimum) to 100 (maximum) with higher scores representing higher maturity which is a favorable (better) outcome. The results reported are the difference between 2 time points (baseline and 6 month follow up). A change in outcome which is negative signifies a worse outcome. Conversely, a positive change signifies improvement.
- Vaginal Wall Elasticity Assessed by Number of Participants Able to Tolerate a Larger Vaginal Dilator Size [ Time Frame: 6 months ]Participants who were able to tolerate a larger dilator size compared to before treatment (representing improvement in vaginal wall elasticity) were marked as "yes" and participants who could not tolerate a larger size (representing no change in vaginal elasticity) were marked as "no".
- Effect of Treatment on Female Sexual Function [ Time Frame: 6 months ]Female Sexual Function Index (FSFI) scores are on a scale of 0 (minimum) to 36 (maximum) with higher scores representing more favorable outcomes. The scores represent the difference between baseline and 6 month follow up. A negative difference signifies worsened function whereas a positive difference signifies improvement.
- Effect of Treatment on Urinary Symptoms [ Time Frame: 6 months ]Urogenital distress inventory (UDI-6) is measures on a scale of 0 (minimum) to 75 (maximum) with higher scores representing less favorable outcomes (more severe urinary symptoms). Data here are presented as mean differences from before and after treatment.
- Rate of Satisfaction of Patients With Treatment [ Time Frame: 6 months ]Patient global impression of improvement (PGI) is a 5-point Likert scale evaluating patient satisfaction after treatment. The 5-point Likert scale for satisfaction indicates 1(Very dissatisfied), 2(Dissatisfied), 3(Same), 4(Satisfied) or 5(Very satisfied). As reported, the responses for level of dissatisfaction after treatment on the Patient Global Index included responses of very dissatisfied and dissatisfied. This is directly out of the questionnaire given to the patient to complete.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691936
|United States, California|
|Stanford, California, United States, 94305|
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, North Carolina|
|Wake Forest Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45220|
|Cleveland, Ohio, United States, 44195|
|United States, Rhode Island|
|Brown Medical School|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Marie F Paraiso, M.D.||The Cleveland Clinic|