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NCT03679702 Clinical Trial

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

Sexual Dysfunction Clinical Trial

— VENUSSSS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03679702
Other study ID # VI-ISRP-034
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 15, 2018
Est. completion date December 1, 2019

Study information
Verified date November 2018
Source Southern California Center for Sexual Health and Survivorship Medicine
Contact Michael Krychman
Phone 949-764-9300
Email mkrychman@icloud.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A pilot study to investigate non-surgical treatment for women who suffer from sexual complaints secondary to SSRI Sexuality Syndrome.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Viveve System
Radiofrequency device utilized in general surgical procedures for electrocoagulation and hemostasis.

Locations
Country Name City State
United States Southern California Center for Sexual Health and Survivorship Medicine Newport Beach California

Sponsors (2)
Lead Sponsor Collaborator
Michael Krychman, MD Viveve Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety - Adverse Events safety of treatment of female sexual dysfunction secondary to SSRI sexuality syndrome baseline to 6 month
Secondary Female Sexual Function Index (FSFI) Female Sexual Function Index total score (Minimum: 2.0) (Maximum: 36), Higher scores are better outcome. baseline to 3 and 6 months
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