Vaginal AtrophyNCT03178825
Hybrid Fractional Laser for Symptoms of Genitourinary Syndrome of Menopause
A study testing Hybrid Fractional Laser in people with Vaginal Atrophy and Sexual Dysfunction, run by Sciton at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Vaginal Atrophy, Sexual Dysfunction, Dyspareunia
- What is being tested?
- Hybrid Fractional Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- 19 May 2017to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Is sexually active (i.e. intravaginal intercourse) or has the potential and desire to be sexually active if symptoms of GSM improve
- Can read, understand and sign informed consent form
Who cannot join
- 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)
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Carolinas Healthcare System
Charlotte, North Carolina, 28207
Women's Pelvic Health Institute
Los Gatos, California, 95032
Louisiana State University
New Orleans, Louisiana, 70112
The Female Pelvic Medicine Institute of Virginia
North Chesterfield, Virginia, 23235
Coyle Institute
Pensacola, Florida, 32514
Woodlands Gynecology & Aesthetics
The Woodlands, Texas, 77384
About this study
Official title: Safety and Efficacy of Hybrid Fractional Laser Treatment for Symptoms of Genitourinary Syndrome of Menopause
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.
Read the detailed description
Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. Improved vaginal tissue health may lead to improvement of symptoms of Genitourinary Syndrome of Menopause (GSM). This multi-centered, 18-month prospective clinical trial will evaluate the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (HFL) as an alternative non-surgical, non-hormonal treatment for symptoms of GSM.
- Conditions
- Vaginal Atrophy, Sexual Dysfunction, Dyspareunia, Vaginal Dryness, Chronic UTI
- Being tested
- Hybrid Fractional Laser
- Medical subject headings
- Sexual Dysfunction, Physiological, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Fractional LaserDevice
Also called diVa
Consecutive and coincident fractional 2940 nm and 1470 nm lasers
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Fractional Laser | Experimental | Hybrid fractional 2940 nm and 1470 nm laser treatment Receives: Device: Hybrid Fractional Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
Change from baseline in Histology
Change from baseline in epithelial thickness, collagen, elastin, vascularity, and fibroblast density.
Measured: 12 months
Change from baseline in Vaginal Health Index Score (VHIS)
A quantitative assessment of vaginal health that evaluates vaginal elasticity, fluid volume, pH, epithelial integrity, and moisture on a scale of 1 to 5.
Measured: 12 months
Change from baseline in Female Sexual Function Index (FSFI)
A multidimensional self-report instrument for assessment of female sexual function.
Measured: 12 months
Change from baseline in Day-to-Day Impact of Vaginal Aging Questionnaire (DIVA)
A multidimensional self-report measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women.
Measured: 12 months
Change from baseline in Clinical Photography
Change from baseline in the appearance of the treatment area.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start19 May 2017
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathan Guerette, MD, Principal investigator, The Female Pelvic Institute of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178825
- Sponsor's protocol ID
- DIVACIP002
- Status last verified
- Aug 2020
- First submitted
- 5 Jun 2017
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Hybrid Fractional Laser Treatment for Symptoms of Genitourinary Syndrome of Menopause
- ClinicalTrials.gov ID
- NCT03178825
- Acronym / sponsor ID
- DIVACIP002
- Conditions
- Vaginal Atrophy, Sexual Dysfunction, Dyspareunia, Vaginal Dryness, Chronic UTI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ScitonIndustry (pharma, biotech, devices)
- Study start
- 19 May 2017 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. Improved vaginal tissue health may lead to improvement of symptoms of Genitourinary Syndrome of Menopause (GSM). This multi-centered, 18-month prospective clinical trial will evaluate the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (HFL) as an alternative non-surgical, non-hormonal treatment for symptoms of GSM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid Fractional Laser | Experimental | Device: Hybrid Fractional LaserHybrid fractional 2940 nm and 1470 nm laser treatment |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Healthy biological female aged between 40 to 70 years
- Is post-menopausal with a AND b OR c
- Is experiencing at least two self-reported symptoms of GSM, such as
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Fractional LaserAlso: diVaConsecutive and coincident fractional 2940 nm and 1470 nm lasers | Device | Hybrid Fractional Laser |
Primary outcome
Change from baseline in Vaginal Maturation Index (VMI)
Time frame: 12 months
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
5 secondary outcomes
Change from baseline in Histology
Time frame: 12 months
Change from baseline in Vaginal Health Index Score (VHIS)
Time frame: 12 months
Change from baseline in Female Sexual Function Index (FSFI)
Time frame: 12 months
Change from baseline in Day-to-Day Impact of Vaginal Aging Questionnaire (DIVA)
Time frame: 12 months
Change from baseline in Clinical Photography
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Guerette, MD principal investigator
The Female Pelvic Institute of Virginia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Fractional Laser in people with Vaginal Atrophy and Sexual Dysfunction, run by Sciton at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Vaginal Maturation Index (VMI) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.