A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome
Not Applicable
- Conditions
- Sexual Dysfunction
- Interventions
- Device: Viveve System
- Registration Number
- NCT03679702
- Lead Sponsor
- Michael Krychman, MD
- Brief Summary
A pilot study to investigate non-surgical treatment for women who suffer from sexual complaints secondary to SSRI Sexuality Syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 10
Inclusion Criteria
- Currently using SSRI for 3 months at a stable dose
Exclusion Criteria
- Pregnant, currently breastfeeding, or breast-fed within the last 6 months
- Has any implantable electrical device that could potentially be affected by use of radiofrequency.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active treatment Viveve System -
- Primary Outcome Measures
Name Time Method Safety - Adverse Events baseline to 6 month safety of treatment of female sexual dysfunction secondary to SSRI sexuality syndrome
- Secondary Outcome Measures
Name Time Method Female Sexual Function Index (FSFI) baseline to 3 and 6 months Female Sexual Function Index total score (Minimum: 2.0) (Maximum: 36), Higher scores are better outcome.
Trial Locations
- Locations (1)
Southern California Center for Sexual Health and Survivorship Medicine
🇺🇸Newport Beach, California, United States