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

Vulvovaginal Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419729
• Other study ID #: 39495014.0.0000.0082
• Status: Completed
• Phase: Phase 3
• First received: April 6, 2015
• Last updated: June 24, 2016
• Start date: March 2015
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Vulvovaginal atrophy (VVA) symptoms are strongly associated with declining ovarian function and estrogen levels in postmenopausal women, having a considerable impact on women's life quality. Topical hormonal therapy and hormonal replacement are widely used to alleviate VVA symptoms. In this context, minimal invasive fractional CO2 laser emerges as an alternative non-hormonal therapy, especially in patients that present contraindications to hormonal therapy. Objective: Compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for VVA and determine the efficacy and possible adverse effects CO2 laser treatment. Materials and Methods: Forty-five postmenopausal women will be randomized in three double-blinded groups of treatment consisting of CO2 laser and placebo of estrogen vaginal cream, placebo of CO2 laser and estrogen vaginal cream and CO2 laser and estrogen vaginal cream. Assessment of baseline characteristics and follow-up will be obtained through self-completion questionnaires (Female Sex Function Index, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Vulvovaginal Symptom Questionnaire and The Menopause-Specific Quality of Life (MENQOL)). Frost Index and Vaginal Health Index (VHI) are part of objective clinical and histologic analyses. Colposcopy, vaginal cytology and middle third lateral vaginal wall biopsy will also be performed at baseline and at week 17.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• 45-65 women with amenorrhea for over 24 months.

• Clinical vaginal atrophy diagnosis.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Vulvovaginal Atrophy

Intervention

Device:
• CO2 laser
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)

Drug:
• Estrogen
Topical estrogen cream treatment: Estriol 1mg daily.
• Placebo of Estrogen
Placebo of topical estrogen cream.

Device:
• Placebo of CO2 laser
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.

Locations

Country	Name	City	State
Brazil	Centro de Atencao a Saude da Mulher	Sao Bernardo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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

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 CO2 laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. — View Citation

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: 10.3109/13697137.20 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urinary Incontinence Improvement	Incontinence Questionnaire-Short Form (ICIQ-SF) will be used in order to evaluate urinary incontinence improvement after treatment.	Baseline, week 10 and week 17	No
Other	Vaginal Health Index Improvement	Evaluation of vaginal wall conditions such as pH, elasticity, bleeding signs, secretion type and consistency and hydration.	Baseline, week 10 and week 17	No
Primary	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	No
Secondary	Vaginal Cytology Improvement	Vaginal cytology will be obtained from the middle third lateral vaginal wall in order to evaluate initial conditions of the vaginal wall and modifications after treatment. Frost Index, Karyopyknotic Index and Eosinophilic Index will be applied to each sample to measure improvement of vaginal atrophy.	Baseline, week 10 and week 17	No
Secondary	Change from Baseline in Female Sex Function Index	Female Sex Function Index will be used to evaluate improvement of vulvovaginal atrophy symptoms.	Baseline, week 10 and week 17	No
Secondary	Change from Baseline in The Menopause-Specific Quality of Life	The Menopause-Specific Quality of Life will be used to evaluate improvement of vulvovaginal atrophy symptoms.	Baseline, week 10 and week 17	No