Conditions: Hot Flashes
Keywords: Postmenopause Hot Flashes Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estrogens Hormones Hormones, Hormone Substitutes Hormone Antagonists
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 454
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 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 arm 2: 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 arm 3: Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator arm 4: 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 arm 5: 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 arm 6: Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator

Interventions: intervention 1: Estradiol transdermal one 90 μL spray intervention 2: Estradiol transdermal spray, two 90 μL sprays intervention 3: Estradiol transdermal three 90 μL sprays intervention 4: Placebo transdermal two 90 μL sprays intervention 5: Placebo transdermal three 90 μL sprays intervention 6: Placebo transdermal one 90 μL spray
Intervention descriptions: intervention 1: Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator intervention 2: 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 intervention 3: 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 intervention 4: 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 intervention 5: 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 intervention 6: Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator

Protocol document: