Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

PHASE3CompletedINTERVENTIONAL
Enrollment

454

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

November 30, 2006

Study Completion Date

November 30, 2006

Conditions
Hot Flashes
Interventions
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

DRUG

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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

Trial Locations (43)

20707

Women's Health Research Ctr., Laurel

23507

University of Eastern Virginia, Norfold

29605

Center for Women's Medicine, Greenville

30134

Atlanta West Women's Center, Douglasville

30342

Radiant Research, Atlanta

33180

South Florida Medical Research, Aventura

33409

Comprehensive Clinical Trials, West Palm Beach

33781

Radiant Research, Pinellas Park

34471

Renstar Medical Research, Ocala

35235

Alabama Clinical Therapeutics, Birmingham

36608

Costal Clinical Research, Mobile

37203

Clinical Research Associates, Nashville

43212

Radiant Research, Columbus

44260

Radiant Research, Mogadore

45005

TriPhase Research, Franklin

45236

Radiant Research, Cincinnati

55318

Ridgeview Research, Chaska

58501

Mid Dakota Clinic, Bismarck

60610

Radiant Research, Chicago

68134

Meridian Clinical Research, Omaha

70002

Benchmark Research, Metairie

70006

Clinical Trials Management, Metairie

72205

Arkansas Women's Center, Little Rock

72401

NEA Womens Clinic, Jonesboro

77033

Baylor College of Medicine, Houston

78229

Radiant Research, San Antonio

78414

Advanced Research Associates, Corpus Christi

78705

Benchmark Research, Austin

80202

Downtown Women's Health Care, Denver

84109

J. Lewis Research, Salt Lake City

85032

Hope Research Institute, Phoenix

Radiant Research, Phoenix

85701

Radiant Research, Tucson

85739

Harmony Clinic, Oro Valley

90404

Pacific Clinical Research, Santa Monica

92103

Dr. Steven Drosman, San Diego

92108

Medical Center for Clinical Research, San Diego

94102

Benchmark Research, San Francisco

94598

Diablo Clinical Research, Walnut Creek

95825

Sacramento Research Medical Grp, Sacramento

96001

Speciality Care for Women, Redding

97504

PMG-South/OB-Gyn Health Ctr., Medford

98405

Tacoma Women's Specialists, Tacoma

Sponsors
All Listed Sponsors
lead

Lumara Health, Inc.

INDUSTRY