NCT01389102

Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: Lumara Health, Inc. · Industry
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	Estradiol transdermal one 90 μL spray	Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
DRUG	Estradiol transdermal spray, two 90 μL sprays	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
DRUG	Estradiol transdermal three 90 μL sprays	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
DRUG	Placebo transdermal two 90 μL sprays	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
DRUG	Placebo transdermal three 90 μL sprays	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
DRUG	Placebo transdermal one 90 μL spray	Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2011-07-07
• Last updated: 2012-06-11
• Results posted: 2012-06-11

Locations

43 sites across 1 country: United States