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Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy

Vulvovaginal Atrophy Clinical Trial

Official title:
Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy

Clinical Trial Summary

The purpose of this study is to assess the safety and the efficacy of a laser in the treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).

Clinical Trial Description

The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece. Subjects will receive a total of three (3) treatments every six (6) weeks (+/-1 week). Subjects will return one week (+/- 3 days) post the first treatment, as well as three (3) months (+/- 2 weeks) and twelve (12) months (+/- 2 weeks) post the third treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02085980
Study type Interventional
Source El. En. SpA
Contact
Status Completed
Phase N/A
Start date March 2014
Completion date November 2015
View Details
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