Title
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
Phase
Phase 3Lead Sponsor
Lumara HealthStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Hot FlashesIntervention/Treatment
estradiol ...Study Participants
454Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.
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.
Placebo transdermal spray, one 90 μL spray applied to 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
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, 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, 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, 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
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
| Event Type | Organ System | Event Term | Placebo Transdermal Three 90 μL Sprays | Placebo Transdermal Two 90 μL Sprays | Placebo Transdermal One 90 μL Spray | Estradiol Transdermal Three 90 μL Sprays | Estradiol Transdermal Two 90 μL Sprays | Estradiol Transdermal One 90 μL Spray |
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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.
