A Viveve Experience Normalizes Untreated Selective Serotonin Reuptake Inhibitor (SSRI) Sexuality Syndrome
VENUSSSS
1 other identifier
interventional
10
1 country
1
Brief Summary
A pilot study to investigate non-surgical treatment for women who suffer from sexual complaints secondary to SSRI Sexuality Syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2018
CompletedFirst Posted
Study publicly available on registry
September 20, 2018
CompletedStudy Start
First participant enrolled
December 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedNovember 21, 2018
November 1, 2018
12 months
September 19, 2018
November 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Safety - Adverse Events
safety of treatment of female sexual dysfunction secondary to SSRI sexuality syndrome
baseline to 6 month
Secondary Outcomes (1)
Female Sexual Function Index (FSFI)
baseline to 3 and 6 months
Study Arms (1)
Active treatment
OTHERInterventions
Radiofrequency device utilized in general surgical procedures for electrocoagulation and hemostasis.
Eligibility Criteria
You may qualify if:
- Currently using SSRI for 3 months at a stable dose
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael Krychman, MDlead
- Viveve Inc.collaborator
Study Sites (1)
Southern California Center for Sexual Health and Survivorship Medicine
Newport Beach, California, 92663, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Michael Krychman, MD
Study Record Dates
First Submitted
September 19, 2018
First Posted
September 20, 2018
Study Start
December 15, 2018
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
November 21, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share