The Vaginal Health Trial

Summary

This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.

Conditions

• Atrophy of Vagina
• Menopause
• Dyspareunia (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.

Sponsors & Collaborators

• University of Minnesota

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Katherine A Guthrie, PhD · Fred Hutchinson Cancer Center

• Susan D Reed, MD · University of Washington

• Andrea Z LaCroix, PhD · University of California, San Diego

• Caroline Mitchell, MD, MPH · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2017-05-31

Completion

2017-07-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations