CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 454 enrolled
Drug / intervention
Estradiol transdermal one 90 μL spray +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01389102
NCT01389102Phase 3Completed
CompareCT.gov

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

Lumara Health, Inc.·interventional·Posted Jul 7, 2011·Updated Jun 11, 2012

In Brief

A Phase 3 clinical trial evaluating Estradiol transdermal one 90 μL spray, Estradiol transdermal spray, two 90 μL sprays, and 4 other interventions for Hot Flashes. Completed, enrolled 454 participants across 43 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHot Flashes
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 7, 2011
Enrollment StartDec 1, 2004
Primary CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.0 years ago

Interventions

Estradiol transdermal one 90 μL spraydrug

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

Estradiol transdermal spray, two 90 μL spraysdrug

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 three 90 μL spraysdrug

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

Placebo transdermal two 90 μL spraysdrug

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 three 90 μL spraysdrug

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 one 90 μL spraydrug

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