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Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy (VeLVET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02691936
Recruitment Status : Completed
First Posted : February 25, 2016
Results First Posted : October 17, 2019
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
Foundation for Female Health Awareness
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrophic Vaginitis Menopause Device: CO2 fractionated vaginal laser Drug: Estrogens, Conjugated (USP) Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause Vaginitis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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".

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
Stanford University
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
Christ Hospital
Cincinnati, Ohio, United States, 45220
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Rhode Island
Brown Medical School
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Cleveland Clinic
Foundation for Female Health Awareness
Investigators
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Principal Investigator: Marie F Paraiso, M.D. The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by The Cleveland Clinic:

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02691936    
Other Study ID Numbers: 15-1570
First Posted: February 25, 2016    Key Record Dates
Results First Posted: October 17, 2019
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by The Cleveland Clinic:
Genitourinary symptoms of menopause
Menopause
Atrophic vaginitis
Additional relevant MeSH terms:
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Vaginitis
Atrophic Vaginitis
Atrophy
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs