72
Participants
Start Date
May 1, 2017
Primary Completion Date
August 31, 2017
Study Completion Date
November 30, 2017
VR101 Device (Efficacy)
Self-insertion of VR101 Device for 7 days, followed by replacement with a fresh VR101Device, until 4 each Devices have been used for 7 days each, with total consecutive device use equal to 28 days
Sham Control Ring
Self-insertion of Sham Ring for 7 days, followed by replacement with a fresh Sham Ring, until 4 each Sham Rings have been used for 7 days each, with total consecutive Sham use equal to 28 days
VR101 Device (Safety)
Following the 4-week use of shams and a 3-week washout period participants randomized to the Safety Study will use a new VR101 device every 7 days for 13 consecutive weeks.
Advanced Clinical Research, Inc. (ACR Idaho), Meridian
Advanced Clinical Research, Inc. (ACR Utah), West Jordan
Lead Sponsor
Collaborators (1)
Advanced Clinical Research Services, LLC
OTHER
Phil Triolo and Associates LC
INDUSTRY
J3 Bioscience, Inc.
INDUSTRY