The Vaginal Health Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

May 31, 2017

Study Completion Date

July 31, 2017

Conditions
Atrophy of VaginaMenopauseDyspareunia (Female)
Interventions
DRUG

Vagifem

One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.

DEVICE

Replens

2.5 gm to be applied vaginally every 3 days over 12 weeks.

OTHER

Placebo tablet

Dispensed in visually identical bottle and tablet form to Vagifem.

OTHER

Placebo gel

Dispensed in visually identical tube and gel form to Replens.

Trial Locations (2)

55455

University of Minnesota, Minneapolis

98101

Kaiser Permanente Washington Health Research Institute, Seattle

All Listed Sponsors
collaborator

University of Minnesota

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

University of California, San Diego

OTHER

collaborator

University of Washington

OTHER

collaborator

Kaiser Permanente

OTHER

lead

Fred Hutchinson Cancer Center

OTHER

NCT02516202 - The Vaginal Health Trial | Biotech Hunter | Biotech Hunter