Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy

Completed · Not applicable · Has a placebo group

Conditions studied: Female Sexual Dysfunction

In brief

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.

Key facts

Study ID

NCT03479229

Run by

Viveve Inc.

People needed

250

Starts

2018-04-20

Expected to finish

2020-03-15

Last updated by the study team

2020-05-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• VIVEVE II Study Site — La Mesa, California, United States
• VIVEVE II Study Site — Orange, California, United States
• VIVEVE II Study Site — Denver, Colorado, United States
• VIVEVE II Study Site — Washington D.C., District of Columbia, United States
• VIVEVE II Study Site — Lake Worth, Florida, United States
• VIVEVE II Study Site — Plantation, Florida, United States
• VIVEVE II Study Site — West Palm Beach, Florida, United States
• VIVEVE II Study Site — Atlanta, Georgia, United States
• VIVEVE II Study Site — Idaho Falls, Idaho, United States
• VIVEVE II Study Site — Kalamazoo, Michigan, United States
• VIVEVE II Study Site — St Louis, Missouri, United States
• VIVEVE II Study Site — Omaha, Nebraska, United States
• VIVEVE II Study Site — New Brunswick, New Jersey, United States
• VIVEVE II Study Site — Albuquerque, New Mexico, United States
• VIVEVE II Study Site — New York, New York, United States
• VIVEVE II Study Site — Raleigh, North Carolina, United States
• VIVEVE II Study Site — Columbus, Ohio, United States
• VIVEVE II Study Site — Jackson, Tennessee, United States
• VIVEVE II Study Site — Tacoma, Washington, United States
• VIVEVE II Study Site — Calgary, Alberta, Canada
• VIVEVE II Study Site — St. Johns, New Foundland, Canada

Full record on ClinicalTrials.gov

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