Vulvovaginal AtrophyNCT03725410
Multi-polar RF and PEMF for Treatment of Symptoms Associated With Vulvovaginal Atrophy
A study testing Venus Fiore Study Treatment in people with Vulvovaginal Atrophy, run by Venus Concept at 2 sites in 2 countries.
Trial summary
This is a multicenter, single-blind, randomized, sham-controlled study utilizing the Venus Fiore™ (MP)2, a table-top device designed to deliver multi-polar RF energy and pulsed electromagnetic fields for use in dermatological and general surgical procedures to temporarily improve blood circulation and to induce… Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Venus Fiore Study Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Sep 2018to 31 Dec 2022
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, female subjects, ≥ 19 years of age, requesting treatment of vulvovaginal tissue for improvement of symptoms associated with vulvovaginal atrophy
- Baseline FSFI score <27.
- At least one full-term vaginal delivery (of more than 36 weeks gestation) completed at least one year before study enrollment.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Sexually active in a monogamous relationship.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.
- Negative Papanicolaou (Pap) Smear Cytology Test within 3 months prior to enrollment.
Who cannot join
- Pregnant or intending to become pregnant during the course of study.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area (e.g. intrauterine device).
- Prior use of collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) in the treated area within 4-6 weeks of the initial treatment or during the course of the study.
- Use of retinoids such as oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.
- Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
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- Open laceration, abrasion or bleeding of any sort on the area to be treated.
- Active sexual transmitted disease (STD) (e.g. genital Herpes Simplex, condylomata) or vaginosis.
- Chronic vulvar pain or vulvar dystrophy.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications, including corticosteroids, 6 months prior to and during the course of the study.
- Having any form of active cancer at the time of enrollment and during the course of the study.
- Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process.
- Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria.
- Mentally incompetent or evidence of active substance or alcohol abuse.
- Having any stage 3-4 cystocele, rectocele, enterocele paravaginal defect or major pelvic organ prolapse beyond the hymenal ring.
- Unstable dosages of medications such as antihypertensives or psychotropics that are known to affect sexuality.
- Skin piercing in the treatment area.
- Tattoos in the treatment area.
- Prior skin treatment with laser in the treated area within 6 months of the initial treatment or during the course of treatment.
- Prior ablative resurfacing procedure in the treated area with laser or other devices within 12 months of the initial treatment or during the course of treatment.
- History of keloid formation or poor wound healing in a previously-injured skin area.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Clinical Evaluation of the Safety and Performance of Using Multi-Polar RF and PEMF Technologies for the Treatment of Symptoms Associated With Vulvovaginal Atrophy
This is a multicenter, single-blind, randomized, sham-controlled study utilizing the Venus Fiore™ (MP)2, a table-top device designed to deliver multi-polar RF energy and pulsed electromagnetic fields for use in dermatological and general surgical procedures to temporarily improve blood circulation and to induce modification of collagen structure, neocollagenesis and angiogenesis for the treatment of symptoms associated with vulvovaginal atrophy.
Read the detailed description
Multicenter, single-blind, randomized, sham-controlled study of multi-polar radio-frequency (RF) and pulsed electro-magnetic field (PEMF) technologies for the treatment of symptoms associated with vulvovaginal atrophy. The study will enroll up to 106 subjects requesting treatment of symptoms of vulvovaginal atrophy (vaginal dryness, decreased lubrication during sexual activity, decreased elasticity, irritation, discomfort during intercourse and discomfort of the vaginal and vulvar tissues in general) in order to have 88 subjects complete the study. Subjects will be randomized in a 1:1 ratio to either multi-polar RF and PEMF technologies or sham treatment and will receive a total of three internal and external treatments with the Venus Fiore™ (MP)2 device at four-week intervals. Study treatment will be administered as per the parameter recommendations as set out in the Venus Fiore™ (MP)2 user manual. Subjects will be followed up at three and six months after their initial treatment. Analysis will be performed on all subjects who receive at least one treatment. Three- and six-month outcomes from the active arm will be compared to data from the sham arm.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Venus Fiore Study Treatment, Venus Fiore Sham Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus Fiore Study TreatmentDevice
Study treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (50 - 70% for up to 15 minutes), externally to the labia (10 - 35% for up to 10 minutes) and externally to the mons pubis (10 - 35% for up to 15 minutes).
Venus Fiore Sham TreatmentDevice
Sham treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (1% for up to 15 minutes), externally to the labia (1% for up to 10 minutes) and externally to the mons pubis (1% for up to 15 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Venus Fiore Study Treatment | Active comparator | Study treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (50 - 70% for up to 15 minutes), externally to the labia (10 - 35% for up to 10 minutes) and externally to the mons pubis (10 - 35% for up to 15 minutes). Receives: Device: Venus Fiore Study Treatment |
| Venus Fiore Sham Treatment | Placebo comparator | Sham treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (1% for up to 15 minutes), externally to the labia (1% for up to 10 minutes) and externally to the mons pubis (1% for up to 15 minutes). Receives: Device: Venus Fiore Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Health Index (VHI)
Proportion of subjects in the active arm as compared to the proportion of the subjects in the sham arm assessed as having improvement in the Vaginal Health Index (VHI) score.
Measured: Three months after initial treatment
Vaginal Health Index (VHI)
Proportion of subjects in the active arm as compared to the proportion of the subjects in the sham arm assessed as having improvement in the Vaginal Health Index (VHI) score.
Measured: Six months after initial treatment
Vaginal Mucus
Report the microscopic changes in vaginal mucus in the study treatment group as compared to the sham treatment group.
Measured: Three months after initial treatment
Vaginal Mucus
Report the microscopic changes in vaginal mucus in the study treatment group as compared to the sham treatment group.
Measured: Six months after initial treatment
Vaginal pH
Report the microscopic changes in vaginal pH in the study treatment group as compared to the sham treatment group.
Measured: Three months after initial treatment
Vaginal pH
Report the microscopic changes in vaginal pH in the study treatment group as compared to the sham treatment group.
Measured: Six months after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start25 Sep 2018
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Gronski, PhD, Study director, Venus Concept Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725410
- Sponsor's protocol ID
- CS1017
- Status last verified
- Feb 2022
- First submitted
- 26 Oct 2018
- Last updated
- 2 Jun 2023
- 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 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Performance of Using Multi-Polar RF and PEMF Technologies for the Treatment of Symptoms Associated With Vulvovaginal Atrophy
- ClinicalTrials.gov ID
- NCT03725410
- Acronym / sponsor ID
- CS1017
- Conditions
- Vulvovaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Oct 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 is a multicenter, single-blind, randomized, sham-controlled study utilizing the Venus Fiore™ (MP)2, a table-top device designed to deliver multi-polar RF energy and pulsed electromagnetic fields for use in dermatological and general surgical procedures to temporarily improve blood circulation and to induce modification of collagen structure, neocollagenesis and angiogenesis for the treatment of symptoms associated with vulvovaginal atrophy.
Detailed description
Multicenter, single-blind, randomized, sham-controlled study of multi-polar radio-frequency (RF) and pulsed electro-magnetic field (PEMF) technologies for the treatment of symptoms associated with vulvovaginal atrophy. The study will enroll up to 106 subjects requesting treatment of symptoms of vulvovaginal atrophy (vaginal dryness, decreased lubrication during sexual activity, decreased elasticity, irritation, discomfort during intercourse and discomfort of the vaginal and vulvar tissues in general) in order to have 88 subjects complete the study. Subjects will be randomized in a 1:1 ratio to either multi-polar RF and PEMF technologies or sham treatment and will receive a total of three internal and external treatments with the Venus Fiore™ (MP)2 device at four-week intervals. Study treatment will be administered as per the parameter recommendations as set out in the Venus Fiore™ (MP)2 user manual. Subjects will be followed up at three and six months after their initial treatment. Analysis will be performed on all subjects who receive at least one treatment. Three- and six-month outcomes from the active arm will be compared to data from the sham arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venus Fiore Study Treatment | Active comparator | Device: Venus Fiore Study TreatmentStudy treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (50 - 70% for up to 15 minutes), externally to the labia (10 - 35% for up to 10 minutes) and externally to the mons pubis (10 - 35% for up to 15 minutes). |
| Venus Fiore Sham Treatment | Placebo comparator | Device: Venus Fiore Sham TreatmentSham treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (1% for up to 15 minutes), externally to the labia (1% for up to 10 minutes) and externally to the mons pubis (1% for up to 15 minutes). |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy, female subjects, ≥ 19 years of age, requesting treatment of vulvovaginal tissue for improvement of symptoms associated with vulvovaginal atrophy
- Baseline FSFI score <27.
- At least one full-term vaginal delivery (of more than 36 weeks gestation) completed at least one year before study enrollment.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
Key exclusion criteria (22 listed)
- Pregnant or intending to become pregnant during the course of study.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area (e.g. intrauterine device).
- Prior use of collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) in the treated area within 4-6 weeks of the initial treatment or during the course of the study.
- Use of retinoids such as oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of 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 |
|---|---|---|
| Venus Fiore Study TreatmentStudy treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (50 - 70% for up to 15 minutes), externally to the labia (10 - 35% for up to 10 minutes) and externally to the mons pubis (10 - 35% for up to 15 minutes). | Device | Venus Fiore Study Treatment |
| Venus Fiore Sham TreatmentSham treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (1% for up to 15 minutes), externally to the labia (1% for up to 10 minutes) and externally to the mons pubis (1% for up to 15 minutes). | Device | Venus Fiore Sham Treatment |
Primary outcome
Vaginal Health Index (VHI)
Time frame: Three months after initial treatment
Proportion of subjects in the active arm as compared to the proportion of the subjects in the sham arm assessed as having improvement in the Vaginal Health Index (VHI) score.
Vaginal Health Index (VHI)
Time frame: Six months after initial treatment
Proportion of subjects in the active arm as compared to the proportion of the subjects in the sham arm assessed as having improvement in the Vaginal Health Index (VHI) score.
Vaginal Mucus
Time frame: Three months after initial treatment
Report the microscopic changes in vaginal mucus in the study treatment group as compared to the sham treatment group.
Vaginal Mucus
Time frame: Six months after initial treatment
Report the microscopic changes in vaginal mucus in the study treatment group as compared to the sham treatment group.
Vaginal pH
Time frame: Three months after initial treatment
Report the microscopic changes in vaginal pH in the study treatment group as compared to the sham treatment group.
Vaginal pH
Time frame: Six months after initial treatment
Report the microscopic changes in vaginal pH in the study treatment group as compared to the sham treatment group.
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 2 Jun 2023.
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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.
Matthew Gronski, PhD study director
Venus Concept Ltd.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venus Fiore Study Treatment in people with Vulvovaginal Atrophy, run by Venus Concept at 2 sites in 2 countries.
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 22 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 2 Jun 2023. 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 Italy, Spain. 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?
Vaginal Health Index (VHI) (time frame: Three months after initial treatment). The study lists 6 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 2 Jun 2023.