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

• Sponsor: El. En. SpA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02085980
• Collaborator: The Christ Hospital (Other), Stanford University (Other)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Duration (Months): 20
• Patients Per Site: 15
• Patients Per Site Per Month: 0.7

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Vulvovaginal Atrophy	Device: Laser treatment	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laser Treatment Laser Treatment	Device: Laser treatment; The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece

Outcome Measures

Primary Outcome Measures

1. 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 [Baseline and at follow up visit at 12 months post last treatment]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94306
2	The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital	West Chester	Ohio	United States	45069

Sponsors and Collaborators

• El. En. SpA
• The Christ Hospital
• Stanford University

Investigators

• Principal Investigator: Mickey Karram, MK, Hospital Physician, The Christ Hospital
• Study Director: Eric Sokol, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: El. En. SpA
• ClinicalTrials.gov Identifier: NCT02085980
• Other Study ID Numbers: ELEN13-VVA-MK01
• First Posted: Mar 13, 2014
• Last Update Posted: Jun 4, 2021
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Atrophy

Study Results

Participant Flow

Arm/Group Title	Laser Treatment
Arm/Group Description	Laser Treatment Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
Period Title: Overall Study
STARTED	30
COMPLETED	27
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Laser Treatment
Arm/Group Description	Laser Treatment Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.6 (8.8)
Sex: Female, Male (Count of Participants)
Female	30 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Laser Treatment
Arm/Group Description	Laser Treatment Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
Measure Participants	30
Count of Participants [Participants]	27 90%

Adverse Events

Arm/Group Title	Laser Treatment
Arm/Group Description	Laser Treatment Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
All Cause Mortality
	Laser Treatment
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Laser Treatment
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Laser Treatment
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.