Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, DyspareuniaNCT03647189
Randomized, Controlled Trial With Hybrid Fractional Laser
A study testing Hybrid Fractional Laser in people with Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia, run by Sciton at 1 site in United States.
Trial summary
This randomized, controlled trial will evaluate hybrid fractional laser treatment for vulvovaginal atrophy in breast cancer survivors and menopausal females 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, Vaginal Dryness, Dyspareunia
- What is being tested?
- Hybrid Fractional Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2018to 15 Jun 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Healthy biological female aged between 40 to 70 years 2. 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 3. Is experiencing at least two self-reported symptoms of GSM, such as
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- Vaginal irritation in the absence of infection
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- 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) 4. Has been experiencing symptoms of GSM for greater than 3 months 5. Is unable due to a medical contraindication or unwilling to receive hormone-based vaginal therapy 6. Early menopause after breast cancer 7. Normal and up to date pap smear, if applicable 8. Is sexually active (i.e. intravaginal intercourse) or has the potential and desire to be sexually active if symptoms of GSM improve 9. Can read, understand and sign informed consent form 10. Has indicated willingness to participate in the study by signing an informed consent form 11. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions
Who cannot join
- 1. Undiagnosed abnormal genital bleeding 2. Has history of pelvic surgery or other energy-based vaginal therapy within 12 months prior to enrollment 3. Previous use of topical estrogen therapy within the last 6 months 4. Has used vaginal creams, moisturizers, lubricants or homeopathic preparations, or received anticoagulants, antiplatelet, thrombolytic, vitamin E or anti-inflammatory within 2 weeks of treatment 5. Has history of heart failure 6. Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q) 7. Has an active sexually transmitted infection (STI) 8. Has signs or symptoms of vulvitis/vaginitis 9. Has signs or symptoms of acute urinary tract infection (UTI) 10. Has participated in any clinical trial involving an investigational drug or procedure within past 30 days 11. The investigator feels that for any reason the subject is not eligible to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled Trial With Hybrid Fractional Laser for Vulvovaginal Atrophy in Breast Cancer Survivors and Menopausal Females
This randomized, controlled trial will evaluate hybrid fractional laser treatment for vulvovaginal atrophy in breast cancer survivors and menopausal females
- 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
Hybrid Fractional Laser
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subjects will be treated with hybrid fractional laser Receives: Device: Hybrid Fractional Laser |
| Control Arm | Placebo comparator | Not described 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 health index score (VHIS)
Scores vaginal health by scoring it from 1(none) - 5(excellent).
Measured: 6 months
Change from baseline in Female sexual function index questionnaire (FSFI)
Scoring 0(minimum) - 5(maximum)
Measured: 6 months
Change from baseline in day-to-day impact of vaginal aging questionnaire
Questionnaire
Measured: 6 months
Change from baseline in histology
Histology
Measured: 3 months
Secondary outcomes (1)
Change from baseline in photography
Photography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start10 Aug 2018
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, DyspareuniaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647189
- Sponsor's protocol ID
- DIVA-001
- Status last verified
- Jun 2021
- First submitted
- 23 Aug 2018
- Last updated
- 18 Jun 2021
- 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial With Hybrid Fractional Laser for Vulvovaginal Atrophy in Breast Cancer Survivors and Menopausal Females
- ClinicalTrials.gov ID
- NCT03647189
- Acronym / sponsor ID
- DIVA-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ScitonIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 27 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.
This randomized, controlled trial will evaluate hybrid fractional laser treatment for vulvovaginal atrophy in breast cancer survivors and menopausal females
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Hybrid Fractional LaserSubjects will be treated with hybrid fractional laser |
| Control Arm | Placebo comparator | Device: Hybrid Fractional Laser |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Healthy biological female aged between 40 to 70 years 2. Is post-menopausal with a AND b OR c:
- <!-- -->
Key exclusion criteria (1 listed)
- 1. Undiagnosed abnormal genital bleeding 2. Has history of pelvic surgery or other energy-based vaginal therapy within 12 months prior to enrollment 3. Previous use of topical estrogen therapy within the last 6 months 4. Has used vaginal creams, moisturizers, lubricants or homeopathic preparations, or received anticoagulants, antiplatelet, thrombolytic, vitamin E or anti-inflammatory within 2 weeks of treatment 5. Has history of heart failure 6. Has equal to or greater than stage III prolapse, according to pelvic organ prolapse quantification system (POP-Q) 7. Has an active sexually transmitted infection (STI) 8. Has signs or symptoms of vulvitis/vaginitis 9. Has signs or symptoms of acute urinary tract infection (UTI) 10. Has participated in any clinical trial involving an investigational drug or procedure within past 30 days 11. The investigator feels that for any reason the subject is not eligible to participate in the study
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 LaserHybrid Fractional Laser | Device | Control Arm, Treatment Arm |
Primary outcome
Change from baseline in Vaginal health index score (VHIS)
Time frame: 6 months
Scores vaginal health by scoring it from 1(none) - 5(excellent).
Change from baseline in Female sexual function index questionnaire (FSFI)
Time frame: 6 months
Scoring 0(minimum) - 5(maximum)
Change from baseline in day-to-day impact of vaginal aging questionnaire
Time frame: 6 months
Questionnaire
Change from baseline in histology
Time frame: 3 months
Histology
1 secondary outcome
Change from baseline in photography
Time frame: 6 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 18 Jun 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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, Sexual Dysfunction, Vaginal Dryness, Dyspareunia, run by Sciton at 1 site 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 11 inclusion and 1 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 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
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 health index score (VHIS) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 18 Jun 2021.