NCT02085980

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: El. En. SpA · Industry
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Vulvovaginal Atrophy

Interventions

Type	Name	Description
DEVICE	Laser treatment	The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-08-01
• Completion: 2015-11-01
• First posted: 2014-03-13
• Last updated: 2021-06-04
• Results posted: 2021-06-04

Locations

2 sites across 1 country: United States