Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

Phase 3

Completed

• Conditions: Hot Flashes
• Interventions: Drug: Placebo transdermal three 90 μL sprays; Drug: Placebo transdermal two 90 μL sprays; Drug: Placebo transdermal one 90 μL spray; Drug: Estradiol transdermal three 90 μL sprays; Drug: Estradiol transdermal spray, two 90 μL sprays; Drug: Estradiol transdermal one 90 μL spray

• Registration Number: NCT01389102
• Lead Sponsor: Lumara Health, Inc.

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.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-07
• Results First Submitted: 2012-02-29
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-08
• Last Update Submitted: 2012-06-08
• Results First Posted: 2012-06-11
• Last Update Posted: 2012-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 454

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo transdermal three 90 μL sprays	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
Placebo transdermal two 90 μL sprays	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
Placebo transdermal one 90 μL spray	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
Estradiol transdermal three 90 μL sprays	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
Estradiol transdermal two 90 μL sprays	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
Estradiol transdermal one 90 μL spray	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

Primary Outcome Measures

Name	Time	Method
Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day	baseline to week 12	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
Mean Change the Severity of Moderate to Severe Vasomotor Symptoms	baseline to week 12 (12 weeks)	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.

Trial Locations

Locations (33)

Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

Costal Clinical Research; 🇺🇸 Mobile, Alabama, United States

Harmony Clinic; 🇺🇸 Oro Valley, Arizona, United States

Hope Research Institute; 🇺🇸 Phoenix, Arizona, United States

Radiant Research; 🇺🇸 San Antonio, Texas, United States

NEA Womens Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Arkansas Women's Center; 🇺🇸 Little Rock, Arkansas, United States

Speciality Care for Women; 🇺🇸 Redding, California, United States

Sacramento Research Medical Grp; 🇺🇸 Sacramento, California, United States

Dr. Steven Drosman; 🇺🇸 San Diego, California, United States

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