Vulvovaginal AtrophyLAAVA2NCT03628092
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
A study testing CO2 Fractional Ablative Laser in people with Vulvovaginal Atrophy and Genitourinary Symptoms and Ill-Defined Conditions, run by Royal North Shore Hospital at 2 sites in Australia.
Trial summary
To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) in women with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Atrophy, Genitourinary Symptoms and Ill-Defined Conditions
- What is being tested?
- CO2 Fractional Ablative Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesAustralia
- Study dates
- 24 Jul 2018to 1 Oct 2021
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with a history of early breast cancer >18 years of age
- At baseline patients must have at least one of five symptoms rated at ≥5 on a 10cm VAS scale. Symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia.
- Three groups of patients will qualify:
- Treatment induced premature menopause ≤45 years of age (eg secondary to chemotherapy or oophorectomy) for >6 months
- Premenopausal women on GNRH (gonadotrophin releasing hormone) agonist + tamoxifen or an aromatase inhibitor
- Postmenopausal women on tamoxifen or an aromatase inhibitor
- Willingness to give written informed consent and willingness to comply with the study
- Up to date pap test / HPV (human papillomavirus) testing
Who cannot join
- Medical contraindication to the use of fractional ablative CO2 laser
- Use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment
- Use of vaginal lubricants or moisturisers 14 days prior to the study treatment
- Active or recent genitourinary infections (<30 days)
- Genital prolapse (grade III)
- Active or symptomatic vulvo-vaginal dermatological conditions (Lichen sclerosus, lichen planus, vulval psoriasis, Chron's disease, Hidradenitis Suppurativa, vulval dermatitis, candida, chronic vulvovaginal candidiasis, vulval intraepithelial neoplasia, genital warts)
- Inability to tolerate the use of fractional ablative CO2 laser (eg vaginismus)
Trial locations and contacts
2 sites in 1 country.
Australia2 sites, 2 recruiting
- Recruiting
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
Antonia Pearson, BMed FRACP, +61402308664, antonia.pearson@sydney.edu.au
Emily Forward, MBBS MBA BSc, +61 2 9462 9657, eforward.derm@gmail.com
- Recruiting
Sydney Adventist Hospital
Wahroonga, New South Wales, 2074
Rebecca Stevenson, +612 9480 6283, Rebecca.Stevenson@sah.org.au
Nina Singh, +612 9480 6280, Nina.Singh@sah.org.au
About this study
To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) in women with breast cancer.
Read the detailed description
LAAVA 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. Patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive "sham" laser treatment (setting of close to zero)
Participants will receive the 3 treatments approximately 4 weeks apart. Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. At the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received "sham" treatment will be allowed to crossover to "active" treatment if they wish.
- Being tested
- CO2 Fractional Ablative Laser, Placebo
- Keywords
- genitourinary symptoms of menopause, CO2 fractional ablative laser, Early breast cancer, Vulvovaginal atrophy, Vaginal dryness, Dyspareunia, Vaginal itch, Dysuria
- Medical subject headings
- Breast Neoplasms, Dyspareunia, Dysuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 Fractional Ablative LaserDevice
Also called Monalisa Touch, Lotus
Vaginal / vulval laser treatment
PlaceboDevice
Sham Device
| Study group | Role | What they receive |
|---|---|---|
| CO2 Fractional Ablative Laser | Active comparator | 3 treatments approximately 4 weeks apart with vaginal/vulval laser Receives: Device: CO2 Fractional Ablative Laser |
| Placebo | Placebo comparator | 3 treatments approximately 4 weeks apart with "sham" laser Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal dryness
Improvement in vaginal dryness on a 10cm visual analog scale (VAS). A 10cm VAS is a scale from 0 to 10 with 0 being no symptoms and 10 being worst symptoms possible.
Measured: 12 weeks after completion of treatment
Secondary outcomes (8)
Other symptoms of vulvovaginal atrophy
Improvement in itch, burning, dysuria, dyspareunia and urinary incontinence of a 10cm visual analog scale (VAS)
Measured: 12 weeks after completion of treatment and 12 months after active treatment
Maturation index
Improvement in maturation index from a vaginal swab (a pathological test: the maturation index counts 200 cells and compares the ratio of parabasal:intermediate:superficial squamous cells. Oestrogen deficient smears will show fewer superficial cells and an increase in parabasals (implies an atrophic picture)
)
Measured: 12 weeks after completion of treatment and 12 months after active treatment
Vaginal pH
Improvement in vaginal pH
Measured: 12 weeks after completion of treatment and 12 months after active treatment
Clinician Assessed Changes
Improvement in vaginal moistness, colour and labia stickiness (moistness and stickiness assessed by a physician as present or not, colour as assessed on a predefined colour chart out of 4 colours).
Measured: 12 weeks after completion of treatment and 12 months after active treatment
Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index
Improvement in QOL assessed on the Vulval Quality of Life Index (VQLI) -a validated tool. The scoring bands of the VQLI includes: 0-5 = no effect on patient's life, 6-13 = small effect on patient's life, 14-23 = moderate effect on patient's life, 24-37 = very large effect on patient's life, 38-45 = extremely large effect on patient's life.
Measured: 12 weeks after completion of treatment and 12 months after active treatment
Sexual Function
Improvement in sexual function assessed on the Female Sexual Function Index (FSFI) - a validated tool
Measured: 12 weeks after completion of treatment and 12 months after active treatment
Satisfaction with treatment assessed on a Likert Scale
Patient satisfaction assessed on Likert Scale - a validated tool scoring from 1 to 5 (1=strongly disagree, 2=disagree, 3= neutral, 4=agree, 5=strongly agree)
Measured: 12 weeks after completion of treatment and 12 months after active treatment
Safety of laser treatment (Side effects)
Side effects reported over the duration of the study will be collected descriptively
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start24 Jul 2018
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Pearson, BMed, Principal investigator, Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628092
- Sponsor's protocol ID
- LAAVA2
- Acronym
- LAAVA2
- Status last verified
- Mar 2020
- First submitted
- 1 Aug 2018
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03628092
- Acronym / sponsor ID
- LAAVA2 / LAAVA2
- Keywords
- genitourinary symptoms of menopause, CO2 fractional ablative laser, Early breast cancer, Vulvovaginal atrophy, Vaginal dryness, Dyspareunia, Vaginal itch, Dysuria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 14 Aug 2018 (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.
To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) in women with breast cancer.
Detailed description
LAAVA 2 is a double blinded randomised placebo/sham-controlled trial assessing whether fractional ablative carbon dioxide is beneficial in improving symptoms in women with a history of early breast cancer. Patients will be randomly assigned in a 1:1 ratio to either active laser treatment or inactive "sham" laser treatment (setting of close to zero)
Participants will receive the 3 treatments approximately 4 weeks apart. Participants will then be followed up at twelve weeks post completion of treatment and twelve months post completion of treatment. At the twelve week follow up visit, after completion of study procedures, patients will be unblinded and those who received "sham" treatment will be allowed to crossover to "active" treatment if they wish.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 Fractional Ablative Laser | Active comparator | Device: CO2 Fractional Ablative Laser3 treatments approximately 4 weeks apart with vaginal/vulval laser |
| Placebo | Placebo comparator | Device: Placebo3 treatments approximately 4 weeks apart with "sham" laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women with a history of early breast cancer >18 years of age
- At baseline patients must have at least one of five symptoms rated at ≥5 on a 10cm VAS scale. Symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia.
- Three groups of patients will qualify:
- Treatment induced premature menopause ≤45 years of age (eg secondary to chemotherapy or oophorectomy) for >6 months
- Premenopausal women on GNRH (gonadotrophin releasing hormone) agonist + tamoxifen or an aromatase inhibitor
Key exclusion criteria (7 listed)
- Medical contraindication to the use of fractional ablative CO2 laser
- Use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment
- Use of vaginal lubricants or moisturisers 14 days prior to the study treatment
- Active or recent genitourinary infections (<30 days)
- Genital prolapse (grade III)
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 |
|---|---|---|
| CO2 Fractional Ablative LaserAlso: Monalisa Touch, LotusVaginal / vulval laser treatment | Device | CO2 Fractional Ablative Laser |
| PlaceboSham Device | Device | Placebo |
Primary outcome
Vaginal dryness
Time frame: 12 weeks after completion of treatment
Improvement in vaginal dryness on a 10cm visual analog scale (VAS). A 10cm VAS is a scale from 0 to 10 with 0 being no symptoms and 10 being worst symptoms possible.
8 secondary outcomes
Other symptoms of vulvovaginal atrophy
Time frame: 12 weeks after completion of treatment and 12 months after active treatment
Maturation index
Time frame: 12 weeks after completion of treatment and 12 months after active treatment
Vaginal pH
Time frame: 12 weeks after completion of treatment and 12 months after active treatment
Clinician Assessed Changes
Time frame: 12 weeks after completion of treatment and 12 months after active treatment
Quality of Life (QOL) of patients assessed on the Vulval Quality of Life Index
Time frame: 12 weeks after completion of treatment and 12 months after active treatment
Sexual Function
Time frame: 12 weeks after completion of treatment and 12 months after active treatment
Satisfaction with treatment assessed on a Likert Scale
Time frame: 12 weeks after completion of treatment and 12 months after active treatment
Safety of laser treatment (Side effects)
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
Related trials for Vulvovaginal Atrophy
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer
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.
Antonia Pearson, BMed principal investigator
Royal North Shore Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 Fractional Ablative Laser in people with Vulvovaginal Atrophy and Genitourinary Symptoms and Ill-Defined Conditions, run by Royal North Shore Hospital at 2 sites in Australia.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonia Pearson, BMed (+61402308664, antonia.pearson@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal dryness (time frame: 12 weeks after completion of treatment). 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 12 Mar 2020.