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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

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

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

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

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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