Clinical trial NCT02419729: Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy
Official title: Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvovaginal Atrophy
Keywords: Vulvovaginal atrophy
Menopause
Fractional CO2 laser
Estrogen cream
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 45
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Vulvovaginal Symptom Questionnaire
timeFrame: Baseline, week 10 and week 17
Secondary outcomes:
measure: Vaginal Cytology Improvement
timeFrame: Baseline, week 10 and week 17
measure: Change from Baseline in Female Sex Function Index
timeFrame: Baseline, week 10 and week 17
measure: Change from Baseline in The Menopause-Specific Quality of Life
timeFrame: Baseline, week 10 and week 17
Other outcomes:
measure: Urinary Incontinence Improvement
timeFrame: Baseline, week 10 and week 17
measure: Vaginal Health Index Improvement
timeFrame: Baseline, week 10 and week 17
Locations:
city: Sao Bernardo
country: Brazil
facility: Centro de Atencao a Saude da Mulher
state: Sao Paulo
Study officials:
affiliation: Faculdade de Medicina do ABC
name: Vera L da Cruz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/j.ijgo.2004.11.003.
citation: Bachman GA. A new option for managing urogenital atrophy in post-menopausal women. Cont Obstet Gynecol 42, pp. 13-28.
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: 10.3109/13697137.2014.899347. Epub 2014 Jun 5.