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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vulvovaginal Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CO2 laser & Estrogen

Effective fractional CO2 laser therapy and effective estrogen vaginal cream

Group Type EXPERIMENTAL

CO2 laser

Intervention Type 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)

Estrogen

Intervention Type DRUG

Topical estrogen cream treatment: Estriol 1mg daily.

CO2 laser & Placebo of Estrogen

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

Group Type ACTIVE_COMPARATOR

CO2 laser

Intervention Type 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)

Placebo of Estrogen

Intervention Type DRUG

Placebo of topical estrogen cream.

Placebo of CO2 laser & Estrogen

Placebo fractional CO2 laser therapy and effective estrogen vaginal cream.

Group Type SHAM_COMPARATOR

Estrogen

Intervention Type DRUG

Topical estrogen cream treatment: Estriol 1mg daily.

Placebo of CO2 laser

Intervention Type 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.

Interventions

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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)

Intervention Type DEVICE

Estrogen

Topical estrogen cream treatment: Estriol 1mg daily.

Intervention Type DRUG

Placebo of Estrogen

Placebo of topical estrogen cream.

Intervention Type DRUG

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.

Intervention Type DEVICE

Other Intervention Names

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Fractionated CO2 laser Estriol 1mg SMARTXIDE2 V2LR - Monalisa Touch - Deka Laser

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No