Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

Lumara Health

Status and phase: Completed; Phase 3

Conditions: Hot Flashes

Treatments: Drug: Estradiol transdermal one 90 μL spray; Drug: Placebo transdermal one 90 μL spray; Drug: Estradiol transdermal three 90 μL sprays; Drug: Estradiol transdermal spray, two 90 μL sprays; Drug: Placebo transdermal three 90 μL sprays; Drug: Placebo transdermal two 90 μL sprays

Study type: Interventional

Funder types: Industry

Identifiers

NCT01389102

EST-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 454 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post menopausal women,
• Ages 35 or older,
• Frequent moderate to severe hot flushes,
• Qualifying general medical health

Exclusion criteria

• Disqualifying gynecological disorders,
• Disqualifying dermatological disorders,
• Disqualifying concurrent conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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454 participants in 6 patient groups, including a placebo group

Placebo transdermal three 90 μL sprays

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo transdermal three 90 μL sprays

Placebo transdermal two 90 μL sprays

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo transdermal two 90 μL sprays

Placebo transdermal one 90 μL spray

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo transdermal one 90 μL spray

Estradiol transdermal three 90 μL sprays

Active Comparator group

Description:

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

Treatment:

Drug: Estradiol transdermal three 90 μL sprays

Estradiol transdermal two 90 μL sprays

Active Comparator group

Description:

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

Treatment:

Drug: Estradiol transdermal spray, two 90 μL sprays

Estradiol transdermal one 90 μL spray

Active Comparator group

Description:

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

Treatment:

Drug: Estradiol transdermal one 90 μL spray