Status:
COMPLETED
Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy
Lead Sponsor:
Viveve Inc.
Conditions:
Female Sexual Dysfunction
Eligibility:
FEMALE
18+ years
Phase:
NA
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 act...
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2020
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03479229
Start Date
April 20 2018
End Date
March 15 2020
Last Update
May 19 2020
Active Locations (21)
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1
VIVEVE II Study Site
La Mesa, California, United States, 91942
2
VIVEVE II Study Site
Orange, California, United States, 92868
3
VIVEVE II Study Site
Denver, Colorado, United States, 80209
4
VIVEVE II Study Site
Washington D.C., District of Columbia, United States, 20036