Vulvovaginal AtrophyNCT04210583
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
A study testing Vulvovaginal Treatment in people with Vulvovaginal Atrophy and Menopause, run by Venus Concept at 1 site in Canada.
Trial summary
Twelve month extension of a previous study of Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia for improvement in skin laxity. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Vulvovaginal Atrophy, Menopause, Menopause Surgical
- What is being tested?
- Vulvovaginal Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 4 Sep 2019to 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 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have completed at least two treatments in the Venus Fiore™ CS0716 study and are at least 6 months post Fiore™ treatment.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Sexual active and in a monogamous relationship
Who cannot join
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treatment area.
- Prior use of collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) in the treatment areaduring the course of the study.
- Use of retinoids such as oral Isotretinoin (Accutane®) 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.
- Open laceration, abrasion or bleeding of any sort on the areas to be treated.
Show all 19Show fewer
- Active sexual transmitted disease (STD) (e.g. genital Herpes Simplex, condylomata) or vaginosis.
- Chronic vulvar pain or vulvar dystrophy.
- Use of immunosuppressive medications, including corticosteroids, 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 study, 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.
- 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 use of psychotropics that are known to affect sexuality.
- Skin piercing in the treatment area.
- Tattoos in the treatment area.
- Prior procedure in the treatment area with laser or other device during the course of the study.
- Use of an intrauterine device during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Polar RF and PEMF Technologies for the Treatment of Vaginal Laxity and for Treatment of the Mons Pubis and Labia for Improvement of Skin Laxity: 12-Month Safety and Efficacy
Twelve month extension of a previous study of Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia for improvement in skin laxity. The study will enroll up to 50 subjects who completed the Venus Fiore CS0716 study for the treatment of vaginal laxity and treatment of the mons pubis and labia for improvement in skin laxity. Subjects will be followed up at least six and twelve months post-treatment. Analysis will be performed on all subjects who complete the six-month and twelve month follow-up visits.
Read the detailed description
Traditional non-surgical treatments to treat vaginal laxity include Kegel exercises or pelvic floor therapy with electrical stimulation of the vaginal musculature to promote muscle strength. Although surgery to tighten the vaginal introitus has been used, pain at the incision site leading to dyspareunia, sometimes for months, limits its use. Surgery is also recommended to reduce protuberant mons pubis and the outer labial lips of the labia majora. Most often, the mons pubis has been treated by fat reduction, either by liposuction or open excision along with a pubic skin lift. Surgery to reduce the excess skin of the labia majora tends to be avoided due to a lack of operative techniques and a fear of creating sexual dysfunction. Development of alternative methods of treatment, avoiding the usual surgical complications is warranted.
The use of non-ablative radiofrequency (RF) therapy has been used previously for the external and internal female genitalia without incident or complications. The use of Multi-Polar RF and PEMF technology was already demonstrated to be safe and efficient in delivering heat to the tissue. A previous study investigated the safety and efficacy of combining these technologies for the treatment of vaginal laxity and in the treatment of the mons pubis and labia for the improvement in skin laxity at four-months post-treatment. Efficacy and safety was confirmed up to 4-months post-treatment. (Venus FioreTM CS0716 study, unpublished raw data). However, the durability of the treatment is not known.
This study will investigate whether Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia is safe and efficacious at six-months and twelve-months post-treatment.
- Conditions
- Vulvovaginal Atrophy, Menopause, Menopause Surgical
- Being tested
- Vulvovaginal Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vulvovaginal TreatmentDevice
Device model(s) - Venus Fiore™ Device settings and programming internal applicator - 42°C - 45°C Temperature output via automatic temperature control (ATC) (optional treatment).
Duration of exposure and frequency of exposure with internal applicator - one treatment for 12-15 minutes at 12 months (optional treatment).
Device settings and programming external mons pubis and labia applicators - 10-35% output (optional treatment).
Duration of exposure and frequency of exposure external applicators - one treament for 15 minutes for the mons pubis, 10 minutes for labia at 12 months (optional treatment).
| Study group | Role | What they receive |
|---|---|---|
| Vulvovaginal Treatment | Experimental | At visit 1 -(6 months post treatment in the CS0716 study):
AE assessment, VLQ, FSFI, GRAS and GAIS (optional), Vaginal pH and vaginal smear (optional),
At Visit 2 (6 months post treatment in the CS0716 study):
AE assessment, VLQ, FSFI, GRAS and GAIS (optional), Vaginal pH and vaginal smear (optional), Administer study treatment (optional: internal, mons pubis and/or labia treatment).
Discomfort/pain 10 cm VAS, immediate response assessment (applicable only if treatment provided)
Final AE follow-up 30 days post Visit 2 Treatment (if applicable): AE assessment (applicable only if treatment provided at Visit 2 in the FE1019 study). Receives: Device: Vulvovaginal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety (Follow-up for any AEs) of the Venus Fiore Fiore™ (MP)2 system in vaginal laxity and skin laxity of the mons pubis and labia.
AE assessment VLQ, FSFI, GRAS and GAIS (optional) Vaginal pH and vaginal smear (optional) Discomfort/pain 10 cm VAS, immediate response assessment (applicable only if treatment provided)
Measured: 6 months
Secondary outcomes (1)
long term safety of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia.
AE assessment VLQ, FSFI, GRAS and GAIS (optional) Vaginal pH and vaginal smear (optional) Administer study treatment (optional: internal, mons pubis and/or labia treatment) Discomfort/pain 10 cm VAS, immediate response assessment (applicable only if treatment provided)
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 posted24 Dec 2019
- Study start4 Sep 2019
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 1. Long term safety of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia. * Subject's assessment of discomfort and pain as measured by a 10 cm visual analog scale (VAS) at 12 months if treatment (optional) is provided. * Subjects experiencing a treatment-related adverse event (AE) at six-months and twelve-months post-treatment. 2. Long term efficacy of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia. * Improvement in vaginal laxity at six-months and twelve-months post-treatment compared to baseline as defined as a score \>4 on the VLQ. * Improvement in FSFI mean score at six-months and twelve-months post-treatment compared to baseline.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathew Gronski, Study director, Venus Concept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210583
- Sponsor's protocol ID
- FE1019
- Status last verified
- May 2023
- First submitted
- 13 Dec 2019
- 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
- Multi-Polar RF and PEMF Technologies for the Treatment of Vaginal Laxity and for Treatment of the Mons Pubis and Labia for Improvement of Skin Laxity: 12-Month Safety and Efficacy
- ClinicalTrials.gov ID
- NCT04210583
- Acronym / sponsor ID
- FE1019
- Conditions
- Vulvovaginal Atrophy, Menopause, Menopause Surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Dec 2019 (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.
Twelve month extension of a previous study of Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia for improvement in skin laxity. The study will enroll up to 50 subjects who completed the Venus Fiore CS0716 study for the treatment of vaginal laxity and treatment of the mons pubis and labia for improvement in skin laxity. Subjects will be followed up at least six and twelve months post-treatment. Analysis will be performed on all subjects who complete the six-month and twelve month follow-up visits.
Detailed description
Traditional non-surgical treatments to treat vaginal laxity include Kegel exercises or pelvic floor therapy with electrical stimulation of the vaginal musculature to promote muscle strength. Although surgery to tighten the vaginal introitus has been used, pain at the incision site leading to dyspareunia, sometimes for months, limits its use. Surgery is also recommended to reduce protuberant mons pubis and the outer labial lips of the labia majora. Most often, the mons pubis has been treated by fat reduction, either by liposuction or open excision along with a pubic skin lift. Surgery to reduce the excess skin of the labia majora tends to be avoided due to a lack of operative techniques and a fear of creating sexual dysfunction. Development of alternative methods of treatment, avoiding the usual surgical complications is warranted.
The use of non-ablative radiofrequency (RF) therapy has been used previously for the external and internal female genitalia without incident or complications. The use of Multi-Polar RF and PEMF technology was already demonstrated to be safe and efficient in delivering heat to the tissue. A previous study investigated the safety and efficacy of combining these technologies for the treatment of vaginal laxity and in the treatment of the mons pubis and labia for the improvement in skin laxity at four-months post-treatment. Efficacy and safety was confirmed up to 4-months post-treatment. (Venus FioreTM CS0716 study, unpublished raw data). However, the durability of the treatment is not known.
This study will investigate whether Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia is safe and efficacious at six-months and twelve-months post-treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1. Long term safety of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia. * Subject's assessment of discomfort and pain as measured by a 10 cm visual analog scale (VAS) at 12 months if treatment (optional) is provided. * Subjects experiencing a treatment-related adverse event (AE) at six-months and twelve-months post-treatment. 2. Long term efficacy of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia. * Improvement in vaginal laxity at six-months and twelve-months post-treatment compared to baseline as defined as a score >4 on the VLQ. * Improvement in FSFI mean score at six-months and twelve-months post-treatment compared to baseline.
| Arm | Type | Receives |
|---|---|---|
| Vulvovaginal Treatment | Experimental | Device: Vulvovaginal TreatmentAt visit 1 -(6 months post treatment in the CS0716 study): AE assessment, VLQ, FSFI, GRAS and GAIS (optional), Vaginal pH and vaginal smear (optional), At Visit 2 (6 months post treatment in the CS0716 study): AE assessment, VLQ, FSFI, GRAS and GAIS (optional), Vaginal pH and vaginal smear (optional), Administer study treatment (optional: internal, mons pubis and/or labia treatment). Discomfort/pain 10 cm VAS, immediate response assessment (applicable only if treatment provided) Final AE follow-up 30 days post Visit 2 Treatment (if applicable): AE assessment (applicable only if treatment provided at Visit 2 in the FE1019 study). |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who have completed at least two treatments in the Venus Fiore™ CS0716 study and are at least 6 months post Fiore™ treatment.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Sexual active and in a monogamous relationship
Key exclusion criteria (19 listed)
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treatment area.
- Prior use of collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) in the treatment areaduring the course of the study.
- Use of retinoids such as oral Isotretinoin (Accutane®) 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.
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 |
|---|---|---|
| Vulvovaginal TreatmentDevice model(s) - Venus Fiore™ Device settings and programming internal applicator - 42°C - 45°C Temperature output via automatic temperature control (ATC) (optional treatment). Duration of exposure and frequency of exposure with internal applicator - one treatment for 12-15 minutes at 12 months (optional treatment). Device settings and programming external mons pubis and labia applicators - 10-35% output (optional treatment). Duration of exposure and frequency of exposure external applicators - one treament for 15 minutes for the mons pubis, 10 minutes for labia at 12 months (optional treatment). | Device | Vulvovaginal Treatment |
Primary outcome
Long term safety (Follow-up for any AEs) of the Venus Fiore Fiore™ (MP)2 system in vaginal laxity and skin laxity of the mons pubis and labia.
Time frame: 6 months
AE assessment VLQ, FSFI, GRAS and GAIS (optional) Vaginal pH and vaginal smear (optional) Discomfort/pain 10 cm VAS, immediate response assessment (applicable only if treatment provided)
1 secondary outcome
long term safety of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia.
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 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.
Mathew Gronski study director
Venus Concept
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vulvovaginal Treatment in people with Vulvovaginal Atrophy and Menopause, run by Venus Concept at 1 site in Canada.
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 4 inclusion and 19 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 1 site in Canada. 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?
Long term safety (Follow-up for any AEs) of the Venus Fiore Fiore™ (MP)2 system in vaginal laxity and skin laxity of the mons pubis and labia. (time frame: 6 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 2 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.