Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
- Conditions
- Hot Flashes
- Interventions
- Drug: Placebo transdermal three 90 μL spraysDrug: Placebo transdermal two 90 μL spraysDrug: Placebo 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 454
- Post menopausal women,
- Ages 35 or older,
- Frequent moderate to severe hot flushes,
- Qualifying general medical health
- 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 activityMean 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Pacific Clinical Research
🇺🇸Santa Monica, California, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Comprehensive Clinical Trials
🇺🇸West Palm Beach, Florida, United States
TriPhase Research
🇺🇸Franklin, Ohio, United States
PMG-South/OB-Gyn Health Ctr.
🇺🇸Medford, Oregon, United States
Advanced Research Associates
🇺🇸Corpus Christi, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Costal Clinical Research
🇺🇸Mobile, Alabama, United States
Downtown Women's Health Care
🇺🇸Denver, Colorado, United States
Mid Dakota Clinic
🇺🇸Bismark, North Dakota, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
Dr. Steven Drosman
🇺🇸San Diego, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Clinical Research Associates
🇺🇸Nashville, Tennessee, United States
J. Lewis Research
🇺🇸Salt Lake City, Utah, United States
Speciality Care for Women
🇺🇸Redding, California, United States
NEA Womens Clinic
🇺🇸Jonesboro, Arkansas, United States
Harmony Clinic
🇺🇸Oro Valley, Arizona, United States
Arkansas Women's Center
🇺🇸Little Rock, Arkansas, United States
Sacramento Research Medical Grp
🇺🇸Sacramento, California, United States
Benchmark Research
🇺🇸Austin, Texas, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Clinical Trials Management
🇺🇸Metairie, Louisiana, United States
Women's Health Research Ctr.
🇺🇸Laurel, Maryland, United States
Atlanta West Women's Center
🇺🇸Douglasville, Georgia, United States
Ridgeview Research
🇺🇸Chaska, Minnesota, United States
Center for Women's Medicine
🇺🇸Greenville, South Carolina, United States
Tacoma Women's Specialists
🇺🇸Tacoma, Washington, United States
University of Eastern Virginia
🇺🇸Norfold, Virginia, United States
Radiant Research
🇺🇸San Antonio, Texas, United States