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

Trial ID or NCT#

NCT02085980

Status

recruiting iconRECRUITING

Purpose

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).

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 45 Years to 60 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. - 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
Exclusion Criteria:
  1. - • 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
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Investigator(s)

Eric R. Sokol, MD
Eric R. Sokol, MD
Urogynecologist, Pelvic surgeon, Minimally invasive gynecologic surgeon, Pelvic reconstructive surgeon, Obstetrician and Gynecologist (OB-GYN)
Associate Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology

Contact us to find out if this trial is right for you.

Contact

Tine Bjornlund
650-724-7826

View on ClinicalTrials.gov