Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389102
• Other study ID #: EST-01
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2011
• Last updated: June 8, 2012
• Start date: December 2004
• Est. completion date: November 2006

Study information

• Verified date: June 2012
• Source: Lumara Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00122200

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes

Intervention

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

Locations

Country	Name	City	State
United States	Radiant Research	Atlanta	Georgia
United States	Benchmark Research	Austin	Texas
United States	South Florida Medical Research	Aventura	Florida
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Mid Dakota Clinic	Bismark	North Dakota
United States	Ridgeview Research	Chaska	Minnesota
United States	Radiant Research	Chicago	Illinois
United States	Radiant Research	Cincinnati	Ohio
United States	Radiant Research	Columbus	Ohio
United States	Advanced Research Associates	Corpus Christi	Texas
United States	Downtown Women's Health Care	Denver	Colorado
United States	Atlanta West Women's Center	Douglasville	Georgia
United States	TriPhase Research	Franklin	Ohio
United States	Center for Women's Medicine	Greenville	South Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	NEA Womens Clinic	Jonesboro	Arkansas
United States	Women's Health Research Ctr.	Laurel	Maryland
United States	Arkansas Women's Center	Little Rock	Arkansas
United States	PMG-South/OB-Gyn Health Ctr.	Medford	Oregon
United States	Benchmark Research	Metairie	Louisiana
United States	Clinical Trials Management	Metairie	Louisiana
United States	Costal Clinical Research	Mobile	Alabama
United States	Radiant Research	Mogadore	Ohio
United States	Clinical Research Associates	Nashville	Tennessee
United States	University of Eastern Virginia	Norfold	Virginia
United States	Renstar Medical Research	Ocala	Florida
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Harmony Clinic	Oro Valley	Arizona
United States	Hope Research Institute	Phoenix	Arizona
United States	Radiant Research	Phoenix	Arizona
United States	Radiant Research	Pinellas Park	Florida
United States	Speciality Care for Women	Redding	California
United States	Sacramento Research Medical Grp	Sacramento	California
United States	J. Lewis Research	Salt Lake City	Utah
United States	Radiant Research	San Antonio	Texas
United States	Dr. Steven Drosman	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	Benchmark Research	San Francisco	California
United States	Pacific Clinical Research	Santa Monica	California
United States	Tacoma Women's Specialists	Tacoma	Washington
United States	Radiant Research	Tucson	Arizona
United States	Diablo Clinical Research	Walnut Creek	California
United States	Comprehensive Clinical Trials	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Lumara Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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)	No