Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
NCT ID: NCT01389102
Last Updated: 2012-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
454 participants
INTERVENTIONAL
2004-12-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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 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 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 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 spray, one 90 μL spray applied to 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
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 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 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 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 spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Ages 35 or older,
* Frequent moderate to severe hot flushes,
* Qualifying general medical health
Exclusion Criteria
* Disqualifying dermatological disorders,
* Disqualifying concurrent conditions
35 Years
FEMALE
No
Sponsors
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Lumara Health, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Phoenix, Arizona, United States
Radiant Research
Tucson, Arizona, 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
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
Diablo Clinical Research
Walnut Creek, California, United States
Downtown Women's Health Care
Denver, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Radiant Research
Pinellas Park, Florida, United States
Comprehensive Clinical Trials
West Palm Beach, Florida, United States
Radiant Research
Atlanta, Georgia, United States
Atlanta West Women's Center
Douglasville, Georgia, United States
Radiant Research
Chicago, Illinois, United States
Benchmark Research
Metairie, Louisiana, United States
Clinical Trials Management
Metairie, Louisiana, United States
Women's Health Research Ctr.
Laurel, Maryland, United States
Ridgeview Research
Chaska, Minnesota, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Radiant Research
Cincinnati, Ohio, United States
Radiant Research
Columbus, Ohio, United States
TriPhase Research
Franklin, Ohio, United States
Radiant Research
Mogadore, Ohio, United States
PMG-South/OB-Gyn Health Ctr.
Medford, Oregon, United States
Center for Women's Medicine
Greenville, South Carolina, United States
Clinical Research Associates
Nashville, Tennessee, United States
Benchmark Research
Austin, Texas, United States
Advanced Research Associates
Corpus Christi, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Radiant Research
San Antonio, Texas, United States
J. Lewis Research
Salt Lake City, Utah, United States
University of Eastern Virginia
Norfold, Virginia, United States
Tacoma Women's Specialists
Tacoma, Washington, United States
Countries
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References
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Buster JE, Koltun WD, Pascual ML, Day WW, Peterson C. Low-dose estradiol spray to treat vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1343-51. doi: 10.1097/AOG.0b013e318175d162.
Other Identifiers
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EST-01
Identifier Type: -
Identifier Source: org_study_id
NCT00122200
Identifier Type: -
Identifier Source: nct_alias
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