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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03679702
Acronym
VENUSSSS
Enrollment
10
Registered
2018-09-20
Start date
2018-12-15
Completion date
2019-12-01
Last updated
2018-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Dysfunction

Brief summary

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

Interventions

DEVICEViveve System

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

Sponsors

Viveve Inc.
CollaboratorINDUSTRY
Michael Krychman, MD
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Safety - Adverse Eventsbaseline to 6 monthsafety of treatment of female sexual dysfunction secondary to SSRI sexuality syndrome

Secondary

MeasureTime frameDescription
Female Sexual Function Index (FSFI)baseline to 3 and 6 monthsFemale Sexual Function Index total score (Minimum: 2.0) (Maximum: 36), Higher scores are better outcome.

Countries

United States

Contacts

Primary ContactMichael Krychman
mkrychman@icloud.com949-764-9300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026