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

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ClinicalTrials.gov Identifier: NCT02691936
Recruitment Status : Suspended (Sponsor requests IDE)
First Posted : February 25, 2016
Last Update Posted : July 18, 2018
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 Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 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
Estimated Primary Completion Date : December 2018
Estimated 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 ]

Secondary Outcome Measures :
  1. Objective evaluation of vaginal atrophy/estrogenization [ Time Frame: 6 months ]
    Vaginal health index (VHI) score

  2. Effect of GMS symptoms on quality of life [ Time Frame: 6 months ]
    DIVA questionnaire

  3. Effect of Treatment on vaginal maturation index [ Time Frame: 6 months ]
    VMI

  4. Effect of treatment on vaginal wall elasticity [ Time Frame: 6 months ]
    vaginal dilator to determine vaginal caliber

  5. Effect of treatment on female sexual function [ Time Frame: 6 months ]
    FSFI

  6. Calculation of percentage of patients who are sexually active or resume intercourse [ Time Frame: 6 months ]
    FSFI

  7. Effect of treatment on urinary symptoms [ Time Frame: 6 months ]
    Urogenital distress inventory (UDI-6)

  8. The degree of difficulty encountered by physician in performing MonaLisa laser treatment [ Time Frame: 6 months ]
    5-point Likert scale

  9. Rate of satisfaction of patients with treatment [ Time Frame: 6 months ]
    Patient global impression of improvement (PGI) using 5-point Likert scale



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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
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
Principal Investigator: Marie F Paraiso, M.D. The Cleveland Clinic

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02691936     History of Changes
Other Study ID Numbers: 15-1570
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
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:
Atrophy
Vaginitis
Atrophic Vaginitis
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs