Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2014

Conditions
Menopausal and Perimenopausal Disorder, UnspecifiedAtrophic Vaginitis
Interventions
DEVICE

Vaginal Lubrication Ring for Vaginal Dryness

"Participants will be asked to complete 4 study visits and one final follow-up phone call. Each study visit will include a brief vaginal exam where vaginal fluid levels and pH levels are checked and questionnaires are completed. Daily diaries will be completed at home and returned to the study staff at subsequent visits.~Participants will self-insert the Intravaginal ring on the 1st study visit. The 2nd study visit will occur 3-4 days later.~The 3rd study visit will occur approximately 7 days after the 1st visit. Participants will remove the device and self-insert a new intravaginal ring.~The 4th study visit will occur approximately 14 days after the first visit. Participants will remove the intravaginal ring and undergo a final vaginal exam.~Participants will be called approximately 7 days after the last visit and will be asked about their current vaginal dryness symptoms and how they felt about the device during the study."

Trial Locations (1)

84132

University of Utah Health Sciences Center, Salt Lake City

Sponsors
All Listed Sponsors
collaborator

University of Utah

OTHER

lead

J3 Bioscience, Inc.

INDUSTRY

NCT02029053 - Preliminary Study of a Vaginal Lubrication Ring to Treat the Symptoms of Vaginal Dryness | Biotech Hunter | Biotech Hunter