Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in
postmenopausal women. This study will evaluate the safety and efficacy of Evamist.

Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

Hot Flashes

Multicenter, randomized, double-blind, placebo-controlled trial evaluating different
doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. The
endpoints are the reduction in frequency and severity of hot flushes.

Estradiol transdermal one 90 μL spray

Estradiol transdermal spray, two 90 μL sprays

Estradiol transdermal three 90 μL sprays

Placebo transdermal two 90 μL sprays

Placebo transdermal three 90 μL sprays

Placebo transdermal one 90 μL spray

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Estradiol Metered-Dose Transdermal Spray (MDTS) in the Treatment of Vasomotor Symptoms in Postmenopausal Women

Patients completed a daily diary to record the number of mild, moderate and number of
moderate or severe vasomotor symptoms [hot flushes and sweating] experienced each day.

Mild, moderate and severe hot flushes and sweating were defined as follows:

Mild = sensation of heat without sweating Moderate = sensation of heat with sweating,
ability to continue activity Severe = sensation of heat with sweating, causing
discontinuation of activity

Patients completed a daily diary to record the number of mild, moderate and severe
vasomotor symptoms experienced each day.

Mild, moderate and severe were defined as follows:

Mild = sensation of heat without sweating Moderate = sensation of heat with sweating,
ability to continue activity Severe = sensation of heat with sweating, causing
discontinuation of activity Severity of hot flushes was measured on a scale of none = 0,
mild = 1, moderate = 2 and severe = 3.

Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on
1 inner forearm daily for 12 weeks using a blinded applicator

Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1
inner forearm daily for 12 weeks using a blinded applicator

Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks
using a blinded applicator

Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas
on 1 inner forearm daily for 12 weeks using a blinded applicator

Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on
1 inner forearm daily for 12 weeks using a blinded applicator

Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12
weeks using a blinded applicator

Alabama Clinical Therapeutics

Costal Clinical Research

Harmony Clinic

Hope Research Institute

Radiant Research

NEA Womens Clinic

Arkansas Women's Center

Speciality Care for Women

Sacramento Research Medical Grp

Dr. Steven Drosman

Medical Center for Clinical Research

Benchmark Research

Pacific Clinical Research

Diablo Clinical Research

Downtown Women's Health Care

South Florida Medical Research

Renstar Medical Research

Comprehensive Clinical Trials

Atlanta West Women's Center

Clinical Trials Management

Women's Health Research Ctr.

Ridgeview Research

Meridian Clinical Research

Mid Dakota Clinic

TriPhase Research

PMG-South/OB-Gyn Health Ctr.

Center for Women's Medicine

Clinical Research Associates

Advanced Research Associates

Baylor College of Medicine

J. Lewis Research

University of Eastern Virginia

Tacoma Women's Specialists

Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status