NCT03178825

Brief Summary

This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 nm lasers for treatment of symptoms of Genitourinary Syndrome of Menopause.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

June 5, 2017

Last Update Submit

August 10, 2020

Conditions

Vaginal AtrophySexual DysfunctionDyspareuniaVaginal DrynessChronic UTI

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Vaginal Maturation Index (VMI)

    An objective assessment of vaginal hormone response as well as overall hormonal environment by calculating a ratio of parabasal cells, intermediate cells, and superficial cells

    12 months

Secondary Outcomes (5)

  • Change from baseline in Histology

    12 months

  • Change from baseline in Vaginal Health Index Score (VHIS)

    12 months

  • Change from baseline in Female Sexual Function Index (FSFI)

    12 months

  • Change from baseline in Day-to-Day Impact of Vaginal Aging Questionnaire (DIVA)

    12 months

  • Change from baseline in Clinical Photography

    12 months

Study Arms (1)

Hybrid Fractional Laser

EXPERIMENTAL

Hybrid fractional 2940 nm and 1470 nm laser treatment

Device: Hybrid Fractional Laser

Interventions

Hybrid Fractional LaserDEVICE

Consecutive and coincident fractional 2940 nm and 1470 nm lasers

Also known as: diVa
Hybrid Fractional Laser

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal Females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy biological female aged between 40 to 70 years
  • Is post-menopausal with a AND b OR c
  • No menses for at least 12 months
  • Follicle-stimulating hormone (FSH) level over 40mlU/mL
  • Has had a bilateral oophorectomy at least 12 months ago with no hormone replacement
  • Is experiencing at least two self-reported symptoms of GSM, such as
  • Vaginal irritation in absence of infection
  • Chronic burning sensation
  • Chronic itching in the absence of infection
  • Recurring urinary tract infections (UTIs)
  • Vaginal dryness during sexual activity
  • Pain during sexual activity (dyspareunia)
  • Has been experiencing symptoms of GSM for greater than 3 months
  • Is unable due to medical contraindication or unwilling to receive hormone-based vaginal therapy
  • Normal and up-to-date pap smear if applicable
  • +2 more criteria

You may not qualify if:

  • Undiagnosed abnormal genital bleeding
  • Has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment
  • Previous use of topical estrogen therapy within the last 3 months
  • Has used vaginal creams, moisturizers, lubricants or homeopathic preparations or received anticoagulants, antiplatelet, thrombolytic, vitamin E or anti-inflammatory within 2 weeks of treatment
  • History of heart failure
  • Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q)
  • Has an active sexually transmitted infection (STI)
  • Has signs or symptoms of vaginitis/vulvitis
  • Has signs or symptoms of acute urinary tract infection (UTI)
  • Has participated in any clinical trial involving an investigational drug or procedure within the past 30 days
  • The investigator feels that for any reason the subject is not eligible to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Women's Pelvic Health Institute

Los Gatos, California, 95032, United States

Location

Coyle Institute

Pensacola, Florida, 32514, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

Carolinas Healthcare System

Charlotte, North Carolina, 28207, United States

Location

Woodlands Gynecology & Aesthetics

The Woodlands, Texas, 77384, United States

Location

The Female Pelvic Medicine Institute of Virginia

North Chesterfield, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalDyspareunia

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, MaleMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Nathan Guerette, MD

    The Female Pelvic Institute of Virginia

    PRINCIPAL INVESTIGATOR

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

June 5, 2017

First Posted

June 7, 2017

Study Start

May 19, 2017

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(6)