Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
Primary Purpose
Vulvovaginal Atrophy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser treatment
Sponsored by

About this trial
This is an interventional treatment trial for Vulvovaginal Atrophy
Eligibility Criteria
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
Sites / Locations
- Stanford University
- The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laser Treatment
Arm Description
Laser Treatment
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02085980
First Posted
March 10, 2014
Last Updated
May 11, 2021
Sponsor
El. En. SpA
Collaborators
The Christ Hospital, Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT02085980
Brief Title
Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
Official Title
Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
El. En. SpA
Collaborators
The Christ Hospital, Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser Treatment
Arm Type
Experimental
Arm Description
Laser Treatment
Intervention Type
Device
Intervention Name(s)
Laser treatment
Intervention Description
The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
Baseline and at follow up visit at 12 months post last treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mickey Karram, MK
Organizational Affiliation
Hospital Physician, The Christ Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Sokol, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States
Facility Name
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12037029
Citation
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. doi: 10.1136/jcp.55.6.446.
Results Reference
result
Learn more about this trial
Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
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