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

Michael Krychman, MD10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Sexual Dysfunction

Interventions

Viveve SystemDEVICE

Radiofrequency device utilized in general surgical procedures for electrocoagulation and hemostasis.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Southern California Center for Sexual Health and Survivorship Medicine

Newport Beach, California, United States

Outcomes

Primary Outcomes

Safety - Adverse Events

safety of treatment of female sexual dysfunction secondary to SSRI sexuality syndrome

Time frame: baseline to 6 month

Secondary Outcomes

Female Sexual Function Index (FSFI)

Female Sexual Function Index total score (Minimum: 2.0) (Maximum: 36), Higher scores are better outcome.

Time frame: baseline to 3 and 6 months

Central Contacts

Michael Krychman

CONTACT

949-764-9300 mkrychman@icloud.com

Data from ClinicalTrials.gov

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