Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women's intimate health, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to continue enrollment in the company's multicenter randomized Viveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy (VIVEVE II) clinical trial to assess the safety and effectiveness of the Viveve System for the improvement of sexual function in women following vaginal childbirth.
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The Agency determined that the company provided sufficient data to support continued subject enrollment in the trial and that there are no safety concerns that preclude the continuation of the study.
“The positive outcome of the safety review by FDA and clearance to advance the VIVEVE II trial to full enrollment represents a significant clinical milestone for Viveve. The VIVEVE II trial has the opportunity to clinically demonstrate that a single treatment with the Viveve System can provide meaningful benefits to women suffering from diminished sexual function following vaginal childbirth. The results of this study, if successful, may support a marketing application for an expanded U.S. indication for the Viveve System for improvement of sexual function,” said Scott Durbin, chief executive officer and director of Viveve.
About the VIVEVE II Study
VIVEVE II is a randomized, double-blinded, and sham-controlled trial with a planned enrollment of approximately 250 subjects at up to 25 study sites in the United States and Canada. Subjects will be randomized in a 1:1 ratio for active and sham treatments.
The primary efficacy endpoint is intended to be the mean change from baseline in the total FSFI (Female Sexual Function Index) at 12 months. Subjects will also be assessed for safety over the 12 months. The approved protocol also includes a variety of secondary and exploratory endpoints measured at six months post-treatment that address the efficacy of and improvement in FSFI domain scores for Desire, Lubrication, Orgasm, Arousal, Satisfaction, and Pain.