NCT02085980

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

June 4, 2021

Completed
Last Updated

June 4, 2021

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

March 10, 2014

Results QC Date

May 11, 2021

Last Update Submit

May 11, 2021

Conditions

Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (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

    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

Study Arms (1)

Laser Treatment

EXPERIMENTAL

Laser Treatment

Device: Laser treatment

Interventions

Laser treatmentDEVICE

The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece

Laser Treatment

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Palo Alto, California, 94306, United States

Location

The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital

West Chester, Ohio, 45069, United States

Location

Related 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. doi: 10.1136/jcp.55.6.446.

    PMID: 12037029RESULT

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Results Point of Contact

Title
Dr. Mickey Karram
Organization
The Christ Hospital - Cincinnati, OH
mickey.karram@thechristhospital.com
(513) 463-2500

Study Officials

  • Mickey Karram, MK

    Hospital Physician, The Christ Hospital

    PRINCIPAL INVESTIGATOR

  • Eric Sokol, MD

    Stanford University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 13, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

November 1, 2015

Last Updated

June 4, 2021

Results First Posted

June 4, 2021

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)