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

Sponsor
ASCEND Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT00160173
Collaborator
Solvay Pharmaceuticals (Industry)
109
Locations

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • ASCEND Therapeutics
    • Solvay Pharmaceuticals

    Investigators

    • Study Director: Global Clinical Director Solvay, Solvay Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ASCEND Therapeutics
    ClinicalTrials.gov Identifier:
    NCT00160173
    Other Study ID Numbers:
    • S166.4.003
    First Posted:
    Sep 12, 2005
    Last Update Posted:
    Jul 15, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by ASCEND Therapeutics
    Post menopausal vasomotor symptoms
    Additional relevant MeSH terms:
    Atrophy
    Estradiol

    Study Results

    No Results Posted as of Jul 15, 2013