Clinical trial NCT01389102: Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hot Flashes
Keywords: Postmenopause
Hot Flashes
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes
Hormone Antagonists
Lead sponsor: Lumara Health, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-07
Enrollment: 454
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day
timeFrame: baseline to week 12
measure: Mean Change the Severity of Moderate to Severe Vasomotor Symptoms
timeFrame: baseline to week 12 (12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Mobile
country: United States
facility: Costal Clinical Research
state: Alabama
city: Oro Valley
country: United States
facility: Harmony Clinic
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Radiant Research
state: Arizona
city: Tucson
country: United States
facility: Radiant Research
state: Arizona
city: Jonesboro
country: United States
facility: NEA Womens Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Women's Center
state: Arkansas
city: Redding
country: United States
facility: Speciality Care for Women
state: California
city: Sacramento
country: United States
facility: Sacramento Research Medical Grp
state: California
city: San Diego
country: United States
facility: Dr. Steven Drosman
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Francisco
country: United States
facility: Benchmark Research
state: California
city: Santa Monica
country: United States
facility: Pacific Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials
state: Florida
city: Atlanta
country: United States
facility: Radiant Research
state: Georgia
city: Douglasville
country: United States
facility: Atlanta West Women's Center
state: Georgia
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management
state: Louisiana
city: Laurel
country: United States
facility: Women's Health Research Ctr.
state: Maryland
city: Chaska
country: United States
facility: Ridgeview Research
state: Minnesota
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Bismark
country: United States
facility: Mid Dakota Clinic
state: North Dakota
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Franklin
country: United States
facility: TriPhase Research
state: Ohio
city: Mogadore
country: United States
facility: Radiant Research
state: Ohio
city: Medford
country: United States
facility: PMG-South/OB-Gyn Health Ctr.
state: Oregon
city: Greenville
country: United States
facility: Center for Women's Medicine
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Corpus Christi
country: United States
facility: Advanced Research Associates
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research
state: Utah
city: Norfold
country: United States
facility: University of Eastern Virginia
state: Virginia
city: Tacoma
country: United States
facility: Tacoma Women's Specialists
state: Washington
Study officials:
References:
citation: 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.