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Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

Primary Purpose

Hot Flashes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Estradiol transdermal one 90 μL spray
Estradiol transdermal spray, two 90 μL sprays
Estradiol transdermal three 90 μL sprays
Placebo transdermal two 90 μL sprays
Placebo transdermal three 90 μL sprays
Placebo transdermal one 90 μL spray
Sponsored by
Lumara Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring Postmenopause, Hot Flashes, Estradiol, Polyestradiol phosphate, Estradiol valerate, Estradiol 3-benzoate, Estradiol 17 beta-cypionate, Estrogens, Hormones, Hormones, Hormone Substitutes, Hormone Antagonists

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Clinical Therapeutics
  • Costal Clinical Research
  • Harmony Clinic
  • Hope Research Institute
  • Radiant Research
  • Radiant Research
  • NEA Womens Clinic
  • Arkansas Women's Center
  • Speciality Care for Women
  • Sacramento Research Medical Grp
  • Dr. Steven Drosman
  • Medical Center for Clinical Research
  • Benchmark Research
  • Pacific Clinical Research
  • Diablo Clinical Research
  • Downtown Women's Health Care
  • South Florida Medical Research
  • Renstar Medical Research
  • Radiant Research
  • Comprehensive Clinical Trials
  • Radiant Research
  • Atlanta West Women's Center
  • Radiant Research
  • Benchmark Research
  • Clinical Trials Management
  • Women's Health Research Ctr.
  • Ridgeview Research
  • Meridian Clinical Research
  • Mid Dakota Clinic
  • Radiant Research
  • Radiant Research
  • TriPhase Research
  • Radiant Research
  • PMG-South/OB-Gyn Health Ctr.
  • Center for Women's Medicine
  • Clinical Research Associates
  • Benchmark Research
  • Advanced Research Associates
  • Baylor College of Medicine
  • Radiant Research
  • J. Lewis Research
  • University of Eastern Virginia
  • Tacoma Women's Specialists

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Placebo Comparator

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo transdermal three 90 μL sprays

Placebo transdermal two 90 μL sprays

Placebo transdermal one 90 μL spray

Estradiol transdermal three 90 μL sprays

Estradiol transdermal two 90 μL sprays

Estradiol transdermal one 90 μL spray

Arm Description

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, 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, one 90 μL spray applied to 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

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, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
July 5, 2011
Last Updated
June 8, 2012
Sponsor
Lumara Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01389102
Brief Title
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumara Health, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
454 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo transdermal three 90 μL sprays
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Placebo transdermal two 90 μL sprays
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Placebo transdermal one 90 μL spray
Arm Type
Placebo Comparator
Arm Description
Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Arm Title
Estradiol transdermal three 90 μL sprays
Arm Type
Active Comparator
Arm Description
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
Arm Title
Estradiol transdermal two 90 μL sprays
Arm Type
Active Comparator
Arm Description
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
Arm Title
Estradiol transdermal one 90 μL spray
Arm Type
Active Comparator
Arm Description
Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Intervention Type
Drug
Intervention Name(s)
Estradiol transdermal one 90 μL spray
Intervention Description
Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Intervention Type
Drug
Intervention Name(s)
Estradiol transdermal spray, two 90 μL sprays
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Estradiol transdermal three 90 μL sprays
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo transdermal two 90 μL sprays
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo transdermal three 90 μL sprays
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo transdermal one 90 μL spray
Intervention Description
Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Primary Outcome Measure Information:
Title
Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day
Description
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
Time Frame
baseline to week 12
Title
Mean Change the Severity of Moderate to Severe Vasomotor Symptoms
Description
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.
Time Frame
baseline to week 12 (12 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Costal Clinical Research
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Harmony Clinic
City
Oro Valley
State/Province
Arizona
ZIP/Postal Code
85739
Country
United States
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Radiant Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Radiant Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85701
Country
United States
Facility Name
NEA Womens Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Arkansas Women's Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Speciality Care for Women
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Sacramento Research Medical Grp
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Dr. Steven Drosman
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Benchmark Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Pacific Clinical Research
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Downtown Women's Health Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Radiant Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Comprehensive Clinical Trials
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Radiant Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta West Women's Center
City
Douglasville
State/Province
Georgia
ZIP/Postal Code
30134
Country
United States
Facility Name
Radiant Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Benchmark Research
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
Clinical Trials Management
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Women's Health Research Ctr.
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
Facility Name
Ridgeview Research
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Mid Dakota Clinic
City
Bismark
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
TriPhase Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Radiant Research
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
PMG-South/OB-Gyn Health Ctr.
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Center for Women's Medicine
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Clinical Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Advanced Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77033
Country
United States
Facility Name
Radiant Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
J. Lewis Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
University of Eastern Virginia
City
Norfold
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Tacoma Women's Specialists
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18515518
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.
Results Reference
derived

Learn more about this trial

Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms

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