Trial record 1 of 6 for:    monalisa
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Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy (VeLVET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by The Cleveland Clinic
Sponsor:
Collaborator:
Foundation for Female Health Awareness
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT02691936
First received: February 22, 2016
Last updated: June 13, 2016
Last verified: June 2016
  Purpose
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 Intervention
Atrophic Vaginitis
Menopause
Device: CO2 fractionated vaginal laser
Drug: Estrogens, Conjugated (USP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Vaginal dryness [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective evaluation of vaginal atrophy/estrogenization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Vaginal health index (VHI) score

  • Effect of GMS symptoms on quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    DIVA questionnaire

  • Effect of Treatment on vaginal maturation index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    VMI

  • Effect of treatment on vaginal wall elasticity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    vaginal dilator to determine vaginal caliber

  • Effect of treatment on female sexual function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    FSFI

  • Calculation of percentage of patients who are sexually active or resume intercourse [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    FSFI

  • Effect of treatment on urinary symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Urogenital distress inventory (UDI-6)

  • The degree of difficulty encountered by physician in performing MonaLisa laser treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    5-point Likert scale

  • Rate of satisfaction of patients with treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient global impression of improvement (PGI) using 5-point Likert scale


Estimated Enrollment: 196
Study Start Date: March 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02691936

Contacts
Contact: Marie F Paraiso, M.D. paraism@ccf.org
Contact: Ly Pung pungl@ccf.org

Locations
United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: Eric Sokol, M.D.       esokol@stanford.edu   
Contact: Kathryn Bantham       kbatham@stanford.edu   
Principal Investigator: Eric Sokol, MD         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Cheryl Iglesia, M.D.       cheryl.iglesia@medstart.net   
Contact: Joanna L Peterson       joanna.l.peterson@medstart.net   
Principal Investigator: Cheryl Iglesia, MD         
United States, North Carolina
Wake Forest Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Catherine Matthews, MD       camatthe@wakehealth.edu   
Contact: Janet Shuping       jshuping@wakehealth.edu   
Principal Investigator: Catherine Matthews, MD         
United States, Ohio
Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Mickey Karram, M.D.       mickey.karram@thechristhospital.com   
Contact: Marsha Zartman       marsha.zartman@thechristhospital.com   
Principal Investigator: Mickey Karram, MD         
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Marie F Paraiso, M.D.       paraism@ccf.org   
Contact: Ly Pung       pungl@ccf.org   
Principal Investigator: Marie Paraiso, MD         
United States, Rhode Island
Brown Medical School Not yet recruiting
Providence, Rhode Island, United States, 02903
Contact: Charles Rardin, M.D.       crardin@wihri.org   
Contact: Ann Meers       ameers@wihri.org   
Principal Investigator: Charles Rardin, MD         
Sponsors and Collaborators
The Cleveland Clinic
Foundation for Female Health Awareness
Investigators
Principal Investigator: Marie F Paraiso, M.D. The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02691936     History of Changes
Other Study ID Numbers: 15-1570 
Study First Received: February 22, 2016
Last Updated: June 13, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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

ClinicalTrials.gov processed this record on July 26, 2016