Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: Estradiol transdermal one 90 μL spray
* Drug: Estradiol transdermal spray, two 90 μL sprays
* Drug: Estradiol transdermal three 90 μL sprays
* Drug: Placebo transdermal two 90 μL sprays
* Drug: Placebo transdermal three 90 μL sprays
* Drug: Placebo transdermal one 90 μL spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo transdermal three 90 μL sprays<br>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 three 90 μL sprays<br>* 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<br>|
| Placebo Comparator: Placebo transdermal two 90 μL sprays<br>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 two 90 μL sprays<br>* 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<br>|
| Placebo Comparator: Placebo transdermal one 90 μL spray<br>Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator | Drug: Placebo transdermal one 90 μL spray<br>* Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator<br>|
| Active Comparator: Estradiol transdermal three 90 μL sprays<br>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: Estradiol transdermal three 90 μL sprays<br>* 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<br>|
| Active Comparator: Estradiol transdermal two 90 μL sprays<br>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 spray, two 90 μL sprays<br>* 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<br>|
| Active Comparator: Estradiol transdermal one 90 μL spray<br>Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator | Drug: Estradiol transdermal one 90 μL spray<br>* Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day | 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 | baseline to week 12 | 
| Mean Change the Severity of Moderate to Severe Vasomotor Symptoms | 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. | baseline to week 12 (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopause, Hot Flashes, Estradiol, Polyestradiol phosphate, Estradiol valerate, Estradiol 3-benzoate, Estradiol 17 beta-cypionate, Estrogens, Hormones, Hormones, Hormone Substitutes, Hormone Antagonists