Viveve Medical has secured the US Food and Drug Administration’s (FDA) approval to continue with Viveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy (VIVEVE II) clinical study.
The trial will assess the safety and effectiveness of the Viveve System for improving the sexual function of women following vaginal childbirth.
The FDA approval was based on a determination that the company provided sufficient data to support continued subject enrolment in the trial and there will not be any subject protection concerns that preclude continuation of the study.
Viveve Medical CEO and director Scott Durbin said: “This clearance to continue enrollment represents a major step forward in the progression of the VIVEVE II trial and for women seeking an improvement in sexual function following child birth. Following FDA review of the second stage of safety data, and approval of an IDE supplement to expand the study, Viveve plans to continue enrollment up to 250 patients.”
The VIVEVE II clinical study will be a randomized, double-blinded and sham-controlled trial with a planned enrollment of about 250 subjects at up to 25 study sites in the US and Canada. Subjects will be randomized in 1:1 ratio for active and sham treatments.
The US regulator required a staged approach for clinical enrollment in its investigational device exemption (IDE) approval letter to Viveve Medical.
The first requested safety review was completed based on one-month follow-up data for the initial 25 subjects in the trial.
A second safety review is now expected to take place after safety data from an additional 25 subjects is collected out to one-month follow-up and from the first 50 subjects at three-month follow-up. As the safety data is being reviewed from the second stage, enrollment in the trial will continue for up to 100 subjects.
The primary efficacy endpoint is intended to be the mean change from baseline in the total FSFI (Female Sexual Function Index) at 12 months. During this time, subjects will also be assessed for safety.
The approved protocol also includes several secondary and exploratory endpoints that are measured at six months post-treatment which will address the efficacy and improvement in FSFI domain scores for desire, lubrication, orgasm, arousal, satisfaction and pain.