Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy

September 8, 2022 updated by: ASCEND Therapeutics

Efficacy Study Comparing 0.9 g and 1.25 g EstroGel® 0.03% Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause

This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study was to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.25 g EstroGel® 0.03% doses with placebo. Effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters.

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Site 112
      • Mobile, Alabama, United States
        • Site 74
      • Montgomery, Alabama, United States
        • Site 20
    • Arizona
      • Tucson, Arizona, United States
        • Site 34
      • Tucson, Arizona, United States
        • Site 68
    • Arkansas
      • Jonesboro, Arkansas, United States
        • Site 5
      • Little Rock, Arkansas, United States
        • Site 88
      • Little Rock, Arkansas, United States
        • Site 95
    • California
      • Carmichael, California, United States
        • Site 104
      • Encinitas, California, United States
        • Site 42
      • San Diego, California, United States
        • Site 21
      • San Diego, California, United States
        • Site 37
      • San Diego, California, United States
        • Site 78
      • San Diego, California, United States
        • Site 82
    • Connecticut
      • Avon, Connecticut, United States
        • Site 69
      • Bridgeport, Connecticut, United States
        • Site 58
      • Groton, Connecticut, United States
        • Site 3
      • Hartford, Connecticut, United States
        • Site 72
      • New Britain, Connecticut, United States
        • Site 54
      • Southport, Connecticut, United States
        • Site 79
      • Waterbury, Connecticut, United States
        • Site 18
      • West Hartford, Connecticut, United States
        • Site 97
    • Florida
      • Aventura, Florida, United States
        • Site 35
      • Aventura, Florida, United States
        • Site 36
      • Clearwater, Florida, United States
        • Site 105
      • Clearwater, Florida, United States
        • Site 49
      • Daytona Beach, Florida, United States
        • Site 91
      • Melbourne, Florida, United States
        • Site 57
      • Miami, Florida, United States
        • Site 109
      • Pinellas Park, Florida, United States
        • Site 39
      • Spring Hill, Florida, United States
        • Site 107
      • Tampa, Florida, United States
        • Site 100
      • West Palm Beach, Florida, United States
        • Site 77
    • Georgia
      • Alpharetta, Georgia, United States
        • Site 61
      • Alpharetta, Georgia, United States
        • Site 81
      • Atlanta, Georgia, United States
        • Site 28
      • Atlanta, Georgia, United States
        • Site 93
      • Decatur, Georgia, United States
        • Site 55
      • Douglasville, Georgia, United States
        • Site 13
      • Powder Springs, Georgia, United States
        • Site 87
      • Savannah, Georgia, United States
        • Site 22
      • Savannah, Georgia, United States
        • Site 99
    • Idaho
      • Boise, Idaho, United States
        • Site 53
    • Illinois
      • Champaign, Illinois, United States
        • Site 96
      • Chicago, Illinois, United States
        • Site 24
      • Chicago, Illinois, United States
        • Site 84
      • Peoria, Illinois, United States
        • Site 26
      • Peoria, Illinois, United States
        • Site 46
    • Indiana
      • Evansville, Indiana, United States
        • Site 75
      • South Bend, Indiana, United States
        • Site 45
    • Iowa
      • Waterloo, Iowa, United States
        • Site 8
    • Kentucky
      • Lexington, Kentucky, United States
        • Site 108
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Site 50
      • Metairie, Louisiana, United States
        • Site 12
      • New Orleans, Louisiana, United States
        • Site 65
      • Shreveport, Louisiana, United States
        • Site 16
    • Maryland
      • Baltimore, Maryland, United States
        • Site 11
    • Michigan
      • Ann Arbor, Michigan, United States
        • Site 66
    • Minnesota
      • Chaska, Minnesota, United States
        • Site 15
    • Missouri
      • Creve Coeur, Missouri, United States
        • Site 29
      • Saint Louis, Missouri, United States
        • Site 2
      • Saint Louis, Missouri, United States
        • Site 67
    • Montana
      • Billings, Montana, United States
        • Site 19
    • Nebraska
      • Lincoln, Nebraska, United States
        • Site 56
    • Nevada
      • Las Vegas, Nevada, United States
        • Site 6
      • Reno, Nevada, United States
        • Site 40
    • New York
      • Olean, New York, United States
        • Site102
    • North Carolina
      • Fayetteville, North Carolina, United States
        • Site 31
      • New Bern, North Carolina, United States
        • Site 60
      • Raleigh, North Carolina, United States
        • Site 59
      • Winston-Salem, North Carolina, United States
        • Site 38
      • Winston-Salem, North Carolina, United States
        • Site 70
      • Winston-Salem, North Carolina, United States
        • Site 85
    • Ohio
      • Cincinnati, Ohio, United States
        • Site 86
    • Oklahoma
      • Edmond, Oklahoma, United States
        • Site 101
    • Oregon
      • Eugene, Oregon, United States
        • Site 89
      • Medford, Oregon, United States
        • Site 111
      • Portland, Oregon, United States
        • Site 64
    • Pennsylvania
      • Erie, Pennsylvania, United States
        • Site 113
      • Pottstown, Pennsylvania, United States
        • Site 98
    • South Carolina
      • Greenville, South Carolina, United States
        • Site 33
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Site 9
      • Memphis, Tennessee, United States
        • Site 92
      • Nashville, Tennessee, United States
        • Site 76
    • Texas
      • Carrollton, Texas, United States
        • Site 83
      • Conroe, Texas, United States
        • Site 17
      • Corpus Christi, Texas, United States
        • Site 23
      • Corpus Christi, Texas, United States
        • Site 25
      • Dallas, Texas, United States
        • Site 30
      • Dallas, Texas, United States
        • Site 90
      • Houston, Texas, United States
        • Site 10
      • Houston, Texas, United States
        • Site 110
      • Houston, Texas, United States
        • Site 14
      • Houston, Texas, United States
        • Site 27
      • Houston, Texas, United States
        • Site 48
      • Houston, Texas, United States
        • Site 51
      • Houston, Texas, United States
        • Site 71
      • Houston, Texas, United States
        • Site 73
      • San Antonio, Texas, United States
        • Site 43
      • San Antonio, Texas, United States
        • Site 62
      • San Antonio, Texas, United States
        • Site 80
      • Texarkana, Texas, United States
        • Site 7
    • Utah
      • Salt Lake City, Utah, United States
        • Site 44
      • Salt Lake City, Utah, United States
        • Site 94
    • Virginia
      • Norfolk, Virginia, United States
        • Site 47
      • Richmond, Virginia, United States
        • Site 106
      • Richmond, Virginia, United States
        • Site 41
    • Washington
      • Seattle, Washington, United States
        • Site 4
      • Tacoma, Washington, United States
        • Site 52

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women 45-65 years
  • naturally or surgically postmenopausal
  • experiencing hot flushes

Exclusion Criteria:

  • hypersensitivity to estrogen replacement therapy
  • pregnancy or lactating
  • abnormal PAP smear
  • history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EstroGel® Gel 0.9 grams 0.03%
0.9 g of EstroGel® 0.03% applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.
Drug: Estrogel
Experimental: EstroGel® Gel 1.25 grams 0.03%
1.25 g of EstroGel® 0.03% applied to one arm and 0.9 g of placebo gel applied on the other arm once daily for 12 weeks.
Drug: Estrogel
Placebo Comparator: Placebo Gel
0.9 g of placebo gel applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.
Other: Placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASCEND Therapeutics

Collaborators

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2004

Primary Completion (Actual)

September 6, 2005

Study Completion (Actual)

September 6, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S166.4.003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postmenopausal Symptoms

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe