Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy

NCT02691936 | Completed Results

• 1 other identifier: 15-1570
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 6

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.

Conditions

Atrophic Vaginitis; Menopause

Keywords

Genitourinary symptoms of menopause; Menopause; Atrophic vaginitis

Outcome Measures

Primary Outcomes (1)

• Vaginal Dryness

  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.

  6 months

Secondary Outcomes (7)

• Objective Evaluation of Vaginal Atrophy/Estrogenization

  6 months

• Effect of GMS Symptoms on Quality of Life

  6 months

• Effect of Treatment on Vaginal Maturation Index

  6 months

• Vaginal Wall Elasticity Assessed by Number of Participants Able to Tolerate a Larger Vaginal Dilator Size

  6 months

• Effect of Treatment on Female Sexual Function

  6 months

Study Arms (2)

CO2 fractionated vaginal laser

EXPERIMENTAL

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

Estrogens, Conjugated (USP)

ACTIVE COMPARATOR

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)

Interventions

CO2 fractionated vaginal laser DEVICE

Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months

Also known as: MonaLisa Touch

CO2 fractionated vaginal laser

Estrogens, Conjugated (USP) DRUG

Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks

Also known as: Vaginal Estrogen cream

Estrogens, Conjugated (USP)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Foundation for Female Health Awareness: collaborator

Study Sites (6)

Stanford University

Stanford, California, 94305, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Christ Hospital

Cincinnati, Ohio, 45220, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Brown Medical School

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

• Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.

  PMID: 40709601 DERIVED

• Paraiso MFR, Ferrando CA, Sokol ER, Rardin CR, Matthews CA, Karram MM, Iglesia CB. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: The VeLVET Trial. Menopause. 2020 Jan;27(1):50-56. doi: 10.1097/GME.0000000000001416.

  PMID: 31574047 DERIVED

MeSH Terms

Conditions

Atrophic Vaginitis

Interventions

Estrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Marie Fidela Paraiso
• Organization: Cleveland Clinic Foundation

PARAISM@ccf.org

216-444-3428

Study Officials

• Marie F Paraiso, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: February 25, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 30, 2019
• Results First Posted: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (6)