Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy

NCT02419729 | Completed Phase 3

• 1 other identifier: 39495014.0.0000.0082
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Forty-five women will be included in a double-blind randomized trial in order to compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for Vulvovaginal Atrophy (VVA) and determine the efficacy and possible adverse effects CO2 laser treatment.

Conditions

Vulvovaginal Atrophy

Keywords

Vulvovaginal atrophy; Menopause; Fractional CO2 laser; Estrogen cream

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Vulvovaginal Symptom Questionnaire

  Vulvovaginal Symptom Questionnaire will be used to evaluate improvement of vulvovaginal atrophy symptoms.

  Baseline, week 10 and week 17

Secondary Outcomes (3)

• Vaginal Cytology Improvement

  Baseline, week 10 and week 17

• Change from Baseline in Female Sex Function Index

  Baseline, week 10 and week 17

• Change from Baseline in The Menopause-Specific Quality of Life

  Baseline, week 10 and week 17

Other Outcomes (2)

• Urinary Incontinence Improvement

  Baseline, week 10 and week 17

• Vaginal Health Index Improvement

  Baseline, week 10 and week 17

Study Arms (3)

CO2 laser & Estrogen

EXPERIMENTAL

Effective fractional CO2 laser therapy and effective estrogen vaginal cream

Device: CO2 laser; Drug: Estrogen

CO2 laser & Placebo of Estrogen

ACTIVE COMPARATOR

Effective fractional CO2 laser therapy and placebo of estrogen vaginal cream.

Device: CO2 laser; Drug: Placebo of Estrogen

Placebo of CO2 laser & Estrogen

SHAM COMPARATOR

Placebo fractional CO2 laser therapy and effective estrogen vaginal cream.

Drug: Estrogen; Device: Placebo of CO2 laser

Interventions

CO2 laser DEVICE

SMARTXIDE2 V2LR (DEKA-Pulse) was used in each application using minimal parameters suggested by the laser's software ( Power of 30 W, 1000us emission time, 1000um spacing and a level of SmartStack 2)

Also known as: Fractionated CO2 laser

CO2 laser & Estrogen; CO2 laser & Placebo of Estrogen

Estrogen DRUG

Topical estrogen cream treatment: Estriol 1mg daily.

Also known as: Estriol 1mg

CO2 laser & Estrogen; Placebo of CO2 laser & Estrogen

Placebo of Estrogen DRUG

Placebo of topical estrogen cream.

CO2 laser & Placebo of Estrogen

Placebo of CO2 laser DEVICE

SMARTXIDE2 V2LR (DEKA-Pulse) was used in each applications using minimal parameters suggested by the laser's software but power of 0.5 W was stipulated for the placebo intervention and other parameters remained unchanged.

Also known as: SMARTXIDE2 V2LR - Monalisa Touch - Deka Laser

Placebo of CO2 laser & Estrogen

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with amenorrhea for over 24 months.
• Clinical vaginal atrophy diagnosis.

You may not qualify if:

• BMI \> 35.
• Previous use of oral estrogen therapy in the last 6 months.
• History or current diagnosis of cancer.
• Altered cervical smear in the last 12 months.
• Renal or hepatic insufficiency.
• Drug-induced menopause.
• Previous use of steroids.
• Previous vaginal radiotherapy therapy.
• Vulvovaginitis.

Sponsors & Collaborators

• Faculdade de Medicina do ABC: lead

Study Sites (1)

Centro de Atencao a Saude da Mulher

São Bernardo do Campo, São Paulo, 09770-210, Brazil

Location

Related Publications (5)

• Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16.

  PMID: 25333211 RESULT

• Society of Obstetricians and Gynaecologists of Canada. SOGC clinical practice guidelines. The detection and management of vaginal atrophy. Number 145, May 2004. Int J Gynaecol Obstet. 2005 Feb;88(2):222-8. doi: 10.1016/j.ijgo.2004.11.003.

  PMID: 15779109 RESULT

• Bachman GA. A new option for managing urogenital atrophy in post-menopausal women. Cont Obstet Gynecol 42, pp. 13-28.

  RESULT

• Salvatore S, Nappi RE, Zerbinati N, Calligaro A, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric. 2014 Aug;17(4):363-9. doi: 10.3109/13697137.2014.899347. Epub 2014 Jun 5.

  PMID: 24605832 RESULT

• 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

MeSH Terms

Interventions

Lasers, Gas; Estrogens; Estriol

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Vera L da Cruz, MD

  Faculdade de Medicina do ABC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 17, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

BR (1)