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

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

Study Overview

• Status: Completed
• Conditions: Hot Flashes
• Intervention / Treatment: Drug: Placebo transdermal three 90 μL sprays; Drug: Placebo transdermal two 90 μL sprays; Drug: Placebo transdermal one 90 μL spray; Drug: Estradiol transdermal three 90 μL sprays; Drug: Estradiol transdermal spray, two 90 μL sprays; Drug: Estradiol transdermal one 90 μL spray

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.

• Study Type: Interventional
• Enrollment (Actual): 454
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Lumara Health, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 7, 2011

Study Record Updates

• Last Update Posted (Estimate): June 11, 2012
• Last Update Submitted That Met QC Criteria: June 8, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Postmenopause; Estradiol; Hormones; Estrogens; Hot Flashes; Hormone Antagonists; Estradiol valerate; Polyestradiol phosphate; Estradiol 3-benzoate; Estradiol 17 beta-cypionate; Hormones, Hormone Substitutes
• Additional Relevant MeSH Terms: Hot Flashes; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate
• Other Study ID Numbers: EST-01