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

ABC Foundation (FUABC)

Status and phase: Completed; Phase 3

Conditions: Vulvovaginal Atrophy

Treatments: Drug: Placebo of Estrogen; Drug: Estrogen; Device: CO2 laser; Device: Placebo of CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT02419729

39495014.0.0000.0082

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

CO2 laser & Estrogen

Experimental group

Description:

Effective fractional CO2 laser therapy and effective estrogen vaginal cream

Treatment:

Device: CO2 laser

Drug: Estrogen

CO2 laser & Placebo of Estrogen

Active Comparator group

Description:

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

Treatment:

Drug: Placebo of Estrogen

Device: CO2 laser

Placebo of CO2 laser & Estrogen

Sham Comparator group

Description:

Placebo fractional CO2 laser therapy and effective estrogen vaginal cream.

Treatment:

Device: Placebo of CO2 laser

Drug: Estrogen