Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness

NACompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

May 1, 2017

Primary Completion Date

August 31, 2017

Study Completion Date

November 30, 2017

Conditions
Menopause Related ConditionsPostmenopausal Symptoms
Interventions
DEVICE

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

OTHER

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

DEVICE

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.

Trial Locations (2)

83642

Advanced Clinical Research, Inc. (ACR Idaho), Meridian

84088

Advanced Clinical Research, Inc. (ACR Utah), West Jordan

All Listed Sponsors
collaborator

Advanced Clinical Research Services, LLC

OTHER

collaborator

Phil Triolo and Associates LC

INDUSTRY

lead

J3 Bioscience, Inc.

INDUSTRY

NCT03150407 - Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness | Biotech Hunter | Biotech Hunter