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

Completed · Not applicable

Conditions studied: Vulvovaginal Atrophy

In brief

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).

Key facts

Study ID

NCT02085980

Run by

El. En. SpA

People needed

30

Starts

2014-03-01

Expected to finish

2015-11-01

Last updated by the study team

2021-06-04

Who can join

Age: 45 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy non-smoking post menopausal women with absence of menstruation of at least 12 months
• Exhibiting VVA symptoms
• Prolapse staged < II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
• Have not had procedures in the anatomical area through 6 months prior to treatment
• Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits

You may not qualify if…

• • Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).
• Prolapse staged ≥ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
• Any serious disease, or chronic condition, that could interfere with the study compliance
• Previously undergone reconstructive pelvic surgery
• Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
• A history of thrombophlebitis
• A history of acute infections
• A history of heart failure
• Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
• Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
• Taking medications that are photosensitive
• A history of keloid formation

Where it is running

• Stanford University — Palo Alto, California, United States
• The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital — West Chester, Ohio, United States

Full record on ClinicalTrials.gov

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