Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lumara Health, Inc.
ClinicalTrials.gov Identifier:
NCT01389102
First received: July 5, 2011
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.


Condition Intervention Phase
Hot Flashes
Drug: Estradiol transdermal one 90 μL spray
Drug: Estradiol transdermal spray, two 90 μL sprays
Drug: Estradiol transdermal three 90 μL sprays
Drug: Placebo transdermal two 90 μL sprays
Drug: Placebo transdermal three 90 μL sprays
Drug: Placebo transdermal one 90 μL spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Lumara Health, Inc.:

Primary Outcome Measures:
  • Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]

    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


  • Mean Change the Severity of Moderate to Severe Vasomotor Symptoms [ Time Frame: baseline to week 12 (12 weeks) ] [ Designated as safety issue: No ]

    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.



Enrollment: 454
Study Start Date: December 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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 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 Comparator: 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 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 Comparator: 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
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
Active Comparator: 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: 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
Active Comparator: 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
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
Active Comparator: 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 one 90 μL spray
Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator

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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389102

  Hide Study Locations
Locations
United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Costal Clinical Research
Mobile, Alabama, United States, 36608
United States, Arizona
Harmony Clinic
Oro Valley, Arizona, United States, 85739
Radiant Research
Phoenix, Arizona, United States, 85032
Hope Research Institute
Phoenix, Arizona, United States, 85032
Radiant Research
Tucson, Arizona, United States, 85701
United States, Arkansas
NEA Womens Clinic
Jonesboro, Arkansas, United States, 72401
Arkansas Women's Center
Little Rock, Arkansas, United States, 72205
United States, California
Speciality Care for Women
Redding, California, United States, 96001
Sacramento Research Medical Grp
Sacramento, California, United States, 95825
Dr. Steven Drosman
San Diego, California, United States, 92103
Medical Center for Clinical Research
San Diego, California, United States, 92108
Benchmark Research
San Francisco, California, United States, 94102
Pacific Clinical Research
Santa Monica, California, United States, 90404
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Colorado
Downtown Women's Health Care
Denver, Colorado, United States, 80202
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Renstar Medical Research
Ocala, Florida, United States, 34471
Radiant Research
Pinellas Park, Florida, United States, 33781
Comprehensive Clinical Trials
West Palm Beach, Florida, United States, 33409
United States, Georgia
Radiant Research
Atlanta, Georgia, United States, 30342
Atlanta West Women's Center
Douglasville, Georgia, United States, 30134
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60610
United States, Louisiana
Clinical Trials Management
Metairie, Louisiana, United States, 70006
Benchmark Research
Metairie, Louisiana, United States, 70002
United States, Maryland
Women's Health Research Ctr.
Laurel, Maryland, United States, 20707
United States, Minnesota
Ridgeview Research
Chaska, Minnesota, United States, 55318
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, North Dakota
Mid Dakota Clinic
Bismark, North Dakota, United States, 58501
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45236
Radiant Research
Columbus, Ohio, United States, 43212
TriPhase Research
Franklin, Ohio, United States, 45005
Radiant Research
Mogadore, Ohio, United States, 44260
United States, Oregon
PMG-South/OB-Gyn Health Ctr.
Medford, Oregon, United States, 97504
United States, South Carolina
Center for Women's Medicine
Greenville, South Carolina, United States, 29605
United States, Tennessee
Clinical Research Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Advanced Research Associates
Corpus Christi, Texas, United States, 78414
Baylor College of Medicine
Houston, Texas, United States, 77033
Radiant Research
San Antonio, Texas, United States, 78229
United States, Utah
J. Lewis Research
Salt Lake City, Utah, United States, 84109
United States, Virginia
University of Eastern Virginia
Norfold, Virginia, United States, 23507
United States, Washington
Tacoma Women's Specialists
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Lumara Health, Inc.
  More Information

No publications provided by Lumara Health, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lumara Health, Inc.
ClinicalTrials.gov Identifier: NCT01389102     History of Changes
Obsolete Identifiers: NCT00122200
Other Study ID Numbers: EST-01
Study First Received: July 5, 2011
Results First Received: February 29, 2012
Last Updated: June 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Lumara Health, Inc.:
Postmenopause
Hot Flashes
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
Hormones
Hormones, Hormone Substitutes
Hormone Antagonists

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 30, 2014