Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy
VIVEVE II
1 other identifier
interventional
250
2 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Typical duration for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedStudy Start
First participant enrolled
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedMay 19, 2020
May 1, 2020
1.9 years
March 19, 2018
May 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months post-treatment
Secondary Outcomes (4)
Incidence of Treatment-Emergent Adverse Events
12 months post-treatment
Female Sexual Function Index (FSFI) Arousal Domain Score
6 months post-treatment
Female Sexual Function Index (FSFI) Orgasm Domain Score
6 months post-treatment
Female Sexual Function Index (FSFI) Total Score
12 months post-treatment
Study Arms (2)
Geneveve Treatment
EXPERIMENTALActive Treatment
Sham Treatment
PLACEBO COMPARATORSham Treatment
Interventions
The active treatment group will receive a treatment dose of 90 J/cm\^2
The sham group will receive a sub-therapeutic dose of ≤ 1 J/cm\^2.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viveve Inc.lead
Study Sites (21)
VIVEVE II Study Site
La Mesa, California, 91942, United States
VIVEVE II Study Site
Orange, California, 92868, United States
VIVEVE II Study Site
Denver, Colorado, 80209, United States
VIVEVE II Study Site
Washington D.C., District of Columbia, 20036, United States
VIVEVE II Study Site
Lake Worth, Florida, 33461, United States
VIVEVE II Study Site
Plantation, Florida, 33324, United States
VIVEVE II Study Site
West Palm Beach, Florida, 33409, United States
VIVEVE II Study Site
Atlanta, Georgia, 30342, United States
VIVEVE II Study Site
Idaho Falls, Idaho, 83404, United States
VIVEVE II Study Site
Kalamazoo, Michigan, 49009, United States
VIVEVE II Study Site
St Louis, Missouri, 63117, United States
VIVEVE II Study Site
Omaha, Nebraska, 68114, United States
VIVEVE II Study Site
New Brunswick, New Jersey, 08901, United States
VIVEVE II Study Site
Albuquerque, New Mexico, 87131, United States
VIVEVE II Study Site
New York, New York, 10038, United States
VIVEVE II Study Site
Raleigh, North Carolina, 27612, United States
VIVEVE II Study Site
Columbus, Ohio, 43221, United States
VIVEVE II Study Site
Jackson, Tennessee, 38305, United States
VIVEVE II Study Site
Tacoma, Washington, 98042, United States
VIVEVE II Study Site
Calgary, Alberta, T2J 6A5, Canada
VIVEVE II Study Site
St. Johns, New Foundland, A1B 3V6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stacie Bell, PhD
Viveve Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2018
First Posted
March 27, 2018
Study Start
April 20, 2018
Primary Completion
March 15, 2020
Study Completion
March 15, 2020
Last Updated
May 19, 2020
Record last verified: 2020-05