A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome

Not Applicable

• Conditions: Sexual Dysfunction

• 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

Study Timeline

• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-20
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-19
• Last Update Posted: 2018-11-21
• Study Start: 2018-12-15
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

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

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