Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
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
1 other identifier
interventional
454
1 country
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2004
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 5, 2011
CompletedFirst Posted
Study publicly available on registry
July 7, 2011
CompletedResults Posted
Study results publicly available
June 11, 2012
CompletedJune 11, 2012
June 1, 2012
1.9 years
July 5, 2011
February 29, 2012
June 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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)
Study Arms (6)
Placebo transdermal three 90 μL sprays
PLACEBO COMPARATORPlacebo 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 COMPARATORPlacebo 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 COMPARATORPlacebo 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
ACTIVE COMPARATOREstradiol 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
ACTIVE COMPARATOREstradiol 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
ACTIVE COMPARATOREstradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Interventions
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 spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
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 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 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 spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Eligibility Criteria
You may qualify if:
- Post menopausal women,
- Ages 35 or older,
- Frequent moderate to severe hot flushes,
- Qualifying general medical health
You may not qualify if:
- Disqualifying gynecological disorders,
- Disqualifying dermatological disorders,
- Disqualifying concurrent conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
Costal Clinical Research
Mobile, Alabama, 36608, United States
Harmony Clinic
Oro Valley, Arizona, 85739, United States
Hope Research Institute
Phoenix, Arizona, 85032, United States
Radiant Research
Phoenix, Arizona, 85032, United States
Radiant Research
Tucson, Arizona, 85701, United States
NEA Womens Clinic
Jonesboro, Arkansas, 72401, United States
Arkansas Women's Center
Little Rock, Arkansas, 72205, United States
Speciality Care for Women
Redding, California, 96001, United States
Sacramento Research Medical Grp
Sacramento, California, 95825, United States
Dr. Steven Drosman
San Diego, California, 92103, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Benchmark Research
San Francisco, California, 94102, United States
Pacific Clinical Research
Santa Monica, California, 90404, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Downtown Women's Health Care
Denver, Colorado, 80202, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Radiant Research
Pinellas Park, Florida, 33781, United States
Comprehensive Clinical Trials
West Palm Beach, Florida, 33409, United States
Radiant Research
Atlanta, Georgia, 30342, United States
Atlanta West Women's Center
Douglasville, Georgia, 30134, United States
Radiant Research
Chicago, Illinois, 60610, United States
Benchmark Research
Metairie, Louisiana, 70002, United States
Clinical Trials Management
Metairie, Louisiana, 70006, United States
Women's Health Research Ctr.
Laurel, Maryland, 20707, United States
Ridgeview Research
Chaska, Minnesota, 55318, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Mid Dakota Clinic
Bismarck, North Dakota, 58501, United States
Radiant Research
Cincinnati, Ohio, 45236, United States
Radiant Research
Columbus, Ohio, 43212, United States
TriPhase Research
Franklin, Ohio, 45005, United States
Radiant Research
Mogadore, Ohio, 44260, United States
PMG-South/OB-Gyn Health Ctr.
Medford, Oregon, 97504, United States
Center for Women's Medicine
Greenville, South Carolina, 29605, United States
Clinical Research Associates
Nashville, Tennessee, 37203, United States
Benchmark Research
Austin, Texas, 78705, United States
Advanced Research Associates
Corpus Christi, Texas, 78414, United States
Baylor College of Medicine
Houston, Texas, 77033, United States
Radiant Research
San Antonio, Texas, 78229, United States
J. Lewis Research
Salt Lake City, Utah, 84109, United States
University of Eastern Virginia
Norfold, Virginia, 23507, United States
Tacoma Women's Specialists
Tacoma, Washington, 98405, United States
Related Publications (1)
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.
PMID: 18515518DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jim Joffrion
- Organization
- KV Pharmaceutical Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2011
First Posted
July 7, 2011
Study Start
December 1, 2004
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
June 11, 2012
Results First Posted
June 11, 2012
Record last verified: 2012-06