Female Sexual DysfunctionVIVEVE IINCT03479229
Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy
A study testing Geneveve Treatment in people with Female Sexual Dysfunction, run by Viveve Inc. at 21 sites in 2 countries.
Trial summary
This study is evaluating the safety and efficacy of the Geneveve Treatment for women experiencing diminished sexual function following vaginal childbirth. Participants will be randomized to either active or sham treatment and followed for 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Geneveve Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 20 Apr 2018to 15 Mar 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age at time of screening and pre-menopausal
- At least one vaginal delivery (> 37 completed weeks gestation)
- Sexual dysfunction
- Negative pregnancy test at Screening visit
- Sexually active
Who cannot join
- Currently breastfeeding or recently discontinued breastfeeding
- Medical history of keloid formation, genital fistula, thin recto-vaginal septum or obstetric trauma
- Implantable electrical device
- Medical or immunological condition
- Chronic use of anti-inflammatory drugs
- Current or previous use of local vaginal hormones
- Undergone previous elective surgical or non-invasive procedure(s) at the vaginal introitus
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
VIVEVE II Study Site
Albuquerque, New Mexico, 87131
VIVEVE II Study Site
Atlanta, Georgia, 30342
VIVEVE II Study Site
Columbus, Ohio, 43221
VIVEVE II Study Site
Denver, Colorado, 80209
VIVEVE II Study Site
Idaho Falls, Idaho, 83404
VIVEVE II Study Site
Jackson, Tennessee, 38305
VIVEVE II Study Site
Kalamazoo, Michigan, 49009
VIVEVE II Study Site
La Mesa, California, 91942
VIVEVE II Study Site
Lake Worth, Florida, 33461
VIVEVE II Study Site
New Brunswick, New Jersey, 08901
VIVEVE II Study Site
New York, New York, 10038
VIVEVE II Study Site
Omaha, Nebraska, 68114
VIVEVE II Study Site
Orange, California, 92868
VIVEVE II Study Site
Plantation, Florida, 33324
VIVEVE II Study Site
Raleigh, North Carolina, 27612
VIVEVE II Study Site
St Louis, Missouri, 63117
VIVEVE II Study Site
Tacoma, Washington, 98042
VIVEVE II Study Site
Washington D.C., District of Columbia, 20036
VIVEVE II Study Site
West Palm Beach, Florida, 33409
Canada2 sites
VIVEVE II Study Site
Calgary, Alberta, T2J 6A5
VIVEVE II Study Site
St. Johns, New Foundland, A1B 3V6
About this study
This study is evaluating the safety and efficacy of the Geneveve Treatment for women experiencing diminished sexual function following vaginal childbirth. Participants will be randomized to either active or sham treatment and followed for 12 months.
Read the detailed description
Decreased sensation and decreased sexual satisfaction following vaginal childbirth has the potential to negatively impact overall sexual function and quality of life in many women. Previous research by obstetricians and gynecologists (OB/GYNs) found that changes in sexual health post-childbirth are not often discussed between physicians and their patients. One possible reason these discussions are not being initiated by physicians is the lack of an evidence-based treatment other than surgery.
While traditional surgery can be performed to improve sexual function following childbirth, pain at incision lines and scarring can lead to dyspareunia for months following the procedure, and a surgical procedure can be painful and the sutures may cause dense scarring. The post-operative recovery may last up to seven days before a woman can return to work. Resuming intercourse is not recommended for at least six weeks after these invasive surgeries. For the many women who are not good surgical candidates, due to health issues or situational limitations on downtime or their unwillingness to undergo a surgical procedure to improve sexual function, there is no other option.
The Geneveve Treatment offers a simple alternative to traditional surgery using non-ablative radiofrequency (RF) energy as a non-surgical approach to improve sexual function following vaginal childbirth. It induces a mild, controlled reaction in the submucosal tissues that stimulates the body to deposit collagen, thereby remodeling the tissue without causing scarring.
This study is designed to demonstrate that active treatment (i.e., Geneveve Treatment) is superior to the sham treatment for the primary efficacy and safety endpoints.
The active treatment group will receive a treatment dose of 90 J/cm^2 and the sham group will receive a sub-therapeutic dose of ≤ 1 J/cm^2. The participant, the investigator, and all study personnel will be blinded to the assignment for the entire study duration.
- Conditions
- Female Sexual Dysfunction
- Being tested
- Geneveve Treatment, Sham Treatment
- Keywords
- vaginal laxity, sexual function, vaginal childbirth, sexual dysfunction, diminished sexual function, satisfaction, arousal, desire, lubrication, orgasm
- Medical subject headings
- Sexual Dysfunction, Physiological, Personal Satisfaction, Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geneveve TreatmentDevice
Also called Active Treatment
The active treatment group will receive a treatment dose of 90 J/cm^2
Sham TreatmentDevice
The sham group will receive a sub-therapeutic dose of ≤ 1 J/cm^2.
| Study group | Role | What they receive |
|---|---|---|
| Geneveve Treatment | Experimental | Active Treatment Receives: Device: Geneveve Treatment |
| Sham Treatment | Placebo comparator | Sham Treatment Receives: Device: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index (FSFI) Total Score
The FSFI is a 19-item validated measure of female sexual function. The FSFI consists of six domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. The recall period is the past 4 weeks. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor. The six domain scores are summed to obtain the full scale score. It should be noted that within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month. The total score is the sum of the domain scores and ranges from 2-36.
Measured: 6 months post-treatment
Secondary outcomes (4)
Incidence of Treatment-Emergent Adverse Events
Safety as reported through Adverse Events from the time the subject signs the consent form through study completion.
Measured: 12 months post-treatment
Female Sexual Function Index (FSFI) Arousal Domain Score
The FSFI is a 19-item validated measure of female sexual function. The FSFI Arousal domain recall period is the past 4 weeks. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor. It should be noted that within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month.
Measured: 6 months post-treatment
Female Sexual Function Index (FSFI) Orgasm Domain Score
The FSFI is a 19-item validated measure of female sexual function. The FSFI Orgasm domain recall period is the past 4 weeks. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor. It should be noted that within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month.
Measured: 6 months post-treatment
Female Sexual Function Index (FSFI) Total Score
The FSFI is a 19-item validated measure of female sexual function. The FSFI consists of six domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. The recall period is the past 4 weeks. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor. The six domain scores are summed to obtain the full scale score. It should be noted that within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month. The total score is the sum of the domain scores and ranges from 2-36.
Measured: 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start20 Apr 2018
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viveve Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacie Bell, PhD, Study director, Viveve Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479229
- Sponsor's protocol ID
- VIVEVE II (VI-15-01)
- Acronym
- VIVEVE II
- Status last verified
- May 2020
- First submitted
- 19 Mar 2018
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy
- ClinicalTrials.gov ID
- NCT03479229
- Acronym / sponsor ID
- VIVEVE II / VIVEVE II (VI-15-01)
- Conditions
- Female Sexual Dysfunction
- Keywords
- vaginal laxity, sexual function, vaginal childbirth, sexual dysfunction, diminished sexual function, satisfaction, arousal, desire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Viveve Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 27 Mar 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 study is evaluating the safety and efficacy of the Geneveve Treatment for women experiencing diminished sexual function following vaginal childbirth. Participants will be randomized to either active or sham treatment and followed for 12 months.
Detailed description
Decreased sensation and decreased sexual satisfaction following vaginal childbirth has the potential to negatively impact overall sexual function and quality of life in many women. Previous research by obstetricians and gynecologists (OB/GYNs) found that changes in sexual health post-childbirth are not often discussed between physicians and their patients. One possible reason these discussions are not being initiated by physicians is the lack of an evidence-based treatment other than surgery.
While traditional surgery can be performed to improve sexual function following childbirth, pain at incision lines and scarring can lead to dyspareunia for months following the procedure, and a surgical procedure can be painful and the sutures may cause dense scarring. The post-operative recovery may last up to seven days before a woman can return to work. Resuming intercourse is not recommended for at least six weeks after these invasive surgeries. For the many women who are not good surgical candidates, due to health issues or situational limitations on downtime or their unwillingness to undergo a surgical procedure to improve sexual function, there is no other option.
The Geneveve Treatment offers a simple alternative to traditional surgery using non-ablative radiofrequency (RF) energy as a non-surgical approach to improve sexual function following vaginal childbirth. It induces a mild, controlled reaction in the submucosal tissues that stimulates the body to deposit collagen, thereby remodeling the tissue without causing scarring.
This study is designed to demonstrate that active treatment (i.e., Geneveve Treatment) is superior to the sham treatment for the primary efficacy and safety endpoints.
The active treatment group will receive a treatment dose of 90 J/cm^2 and the sham group will receive a sub-therapeutic dose of ≤ 1 J/cm^2. The participant, the investigator, and all study personnel will be blinded to the assignment for the entire study duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geneveve Treatment | Experimental | Device: Geneveve TreatmentActive Treatment |
| Sham Treatment | Placebo comparator | Device: Sham TreatmentSham Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age at time of screening and pre-menopausal
- At least one vaginal delivery (> 37 completed weeks gestation)
- Sexual dysfunction
- Negative pregnancy test at Screening visit
- Sexually active
Key exclusion criteria (7 listed)
- Currently breastfeeding or recently discontinued breastfeeding
- Medical history of keloid formation, genital fistula, thin recto-vaginal septum or obstetric trauma
- Implantable electrical device
- Medical or immunological condition
- Chronic use of anti-inflammatory drugs
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 |
|---|---|---|
| Geneveve TreatmentAlso: Active TreatmentThe active treatment group will receive a treatment dose of 90 J/cm^2 | Device | Geneveve Treatment |
| Sham TreatmentThe sham group will receive a sub-therapeutic dose of ≤ 1 J/cm^2. | Device | Sham Treatment |
Primary outcome
Female Sexual Function Index (FSFI) Total Score
Time frame: 6 months post-treatment
The FSFI is a 19-item validated measure of female sexual function. The FSFI consists of six domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. The recall period is the past 4 weeks. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor. The six domain scores are summed to obtain the full scale score. It should be noted that within the individual domains, a domain score of zero indicates that the subject reported having no sexual activity during the past month. The total score is the sum of the domain scores and ranges from 2-36.
4 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 12 months post-treatment
Female Sexual Function Index (FSFI) Arousal Domain Score
Time frame: 6 months post-treatment
Female Sexual Function Index (FSFI) Orgasm Domain Score
Time frame: 6 months post-treatment
Female Sexual Function Index (FSFI) Total Score
Time frame: 12 months post-treatment
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 19 May 2020.
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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.
Stacie Bell, PhD study director
Viveve Inc.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geneveve Treatment in people with Female Sexual Dysfunction, run by Viveve Inc. at 21 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 5 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: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, 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. 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?
Female Sexual Function Index (FSFI) Total Score (time frame: 6 months post-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 19 May 2020.