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

Phase 3

Completed

• Conditions: Vulvovaginal Atrophy
• Interventions: Device: CO2 laser; Drug: Estrogen; Drug: Placebo of Estrogen; Device: Placebo of CO2 laser

• Registration Number: NCT02419729
• Lead Sponsor: Faculdade de Medicina do ABC

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.

Detailed 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-17
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-24
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CO2 laser & Estrogen	CO2 laser	Effective fractional CO2 laser therapy and effective estrogen vaginal cream
CO2 laser & Estrogen	Estrogen	Effective fractional CO2 laser therapy and effective estrogen vaginal cream
CO2 laser & Placebo of Estrogen	CO2 laser	Effective fractional CO2 laser therapy and placebo of estrogen vaginal cream.
CO2 laser & Placebo of Estrogen	Placebo of Estrogen	Effective fractional CO2 laser therapy and placebo of estrogen vaginal cream.
Placebo of CO2 laser & Estrogen	Estrogen	Placebo fractional CO2 laser therapy and effective estrogen vaginal cream.
Placebo of CO2 laser & Estrogen	Placebo of CO2 laser	Placebo fractional CO2 laser therapy and effective estrogen vaginal cream.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Vulvovaginal Symptom Questionnaire	Baseline, week 10 and week 17	Vulvovaginal Symptom Questionnaire will be used to evaluate improvement of vulvovaginal atrophy symptoms.

Secondary Outcome Measures

Name	Time	Method
Vaginal Cytology Improvement	Baseline, week 10 and week 17	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.
Change from Baseline in Female Sex Function Index	Baseline, week 10 and week 17	Female Sex Function Index will be used to evaluate improvement of vulvovaginal atrophy symptoms.
Change from Baseline in The Menopause-Specific Quality of Life	Baseline, week 10 and week 17	The Menopause-Specific Quality of Life will be used to evaluate improvement of vulvovaginal atrophy symptoms.

Trial Locations

Locations (1)

Centro de Atencao a Saude da Mulher; 🇧🇷 Sao Bernardo, Sao Paulo, Brazil