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 Details — Status: Completed

Administrative data

• NCT number: NCT02085980
• Other study ID #: ELEN13-VVA-MK01
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: November 2015

Study information

• Verified date: February 2017
• Source: El. En. SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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:

• • 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

Related Conditions & MeSH terms

• Atrophy
• Vulvovaginal Atrophy

Intervention

Device:
• Laser treatment
The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California
United States	The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital	West Chester	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
El. En. SpA	Stanford University, The Christ Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

van der Laak JA, de Bie LM, de Leeuw H, de Wilde PC, Hanselaar AG. The effect of Replens on vaginal cytology in the treatment of postmenopausal atrophy: cytomorphology versus computerised cytometry. J Clin Pathol. 2002 Jun;55(6):446-51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline	The main outcome of the study is the efficacy of the laser procedure, intended as the amelioration of 50% of the severity of the vaginal dryness at 12 months, compared with baseline.; The change in the vaginal dryness symptom has been assessed by means of a visual analogic scale (10 cm VAS).	Baseline and at follow up visit at 12 months post last treatment