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Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes - Article


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Menopause

Hot Flashes 



Clinical Trial: Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

This study is currently recruiting patients.
Verified by Solvay Pharmaceuticals September 2005

Sponsored by: Solvay Pharmaceuticals
Information provided by: Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160342

Purpose

This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women
Condition Intervention Phase
Hot flashes, menopause, postmenopause
  Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
 Phase II

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women

Eligibility

Ages Eligible for Study:  45 Years   -   65 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

  1. Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
  2. Be a female of any race between the ages of 45-65 years, in generally good health,
  3. Be either naturally or surgically postmenopausal (with or without a uterus)

Exclusion Criteria:

  1. Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
  2. History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00160342

Sheri Rhodes       sheri.rhodes@solvay.com

Alabama
      Site 37, Montgomery,  Alabama,  United States; Recruiting
See central contact

      Site 69, Montgomery,  Alabama,  United States; Recruiting
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Arizona
      Site 44, Tucson,  Arizona,  United States; Recruiting
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Arkansas
      Site 6, Jonesboro,  Arkansas,  United States; Recruiting
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      Site 62, Little Rock,  Arkansas,  United States; Recruiting
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California
      Site 18, San Diego,  California,  United States; Recruiting
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      Site 27, San Diego,  California,  United States; Recruiting
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      Site 31, Vista,  California,  United States; Recruiting
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      Site 54, San Diego,  California,  United States; Recruiting
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      Site 68, Walnut Creek,  California,  United States; Recruiting
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      Site 70, Carmichael,  California,  United States; Recruiting
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      Site 85, Carmichael,  California,  United States; Recruiting
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      Site 87, Northridge,  California,  United States; Recruiting
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Colorado
      Site 66, Denver,  Colorado,  United States; Recruiting
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Connecticut
      Site 4, Groton,  Connecticut,  United States; Recruiting
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      Site 14, Waterbury,  Connecticut,  United States; Recruiting
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      Site 35, New Britain,  Connecticut,  United States; Recruiting
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Florida
      Site 1, Palm Beach,  Florida,  United States; Recruiting
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      Site 9, Venice,  Florida,  United States; Recruiting
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      Site 21, Stuart,  Florida,  United States; Recruiting
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      Site 25, Aventura,  Florida,  United States; Recruiting
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      Site 26, Aventura,  Florida,  United States; Not yet recruiting
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      Site 33, Pensacola,  Florida,  United States; Recruiting
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      Site 51, Clearwater,  Florida,  United States; Not yet recruiting
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      Site 61, Daytona Beach,  Florida,  United States; Recruiting
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      Site 71, Clearwater,  Florida,  United States; Recruiting
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      Site 75, Gainesville,  Florida,  United States; Recruiting
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      Site 82, Tampa,  Florida,  United States; Recruiting
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      Site 83, West Palm Beach,  Florida,  United States; Not yet recruiting
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Georgia
      Site 8, Atlanta,  Georgia,  United States; Recruiting
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      Site 23, Atlanta,  Georgia,  United States; Recruiting
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      Site 40, Atlanta,  Georgia,  United States; Recruiting
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      Site 55, Savannah,  Georgia,  United States; Recruiting
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      Site 60, Powder Springs,  Georgia,  United States; Recruiting
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      Site 90, Alpharetta,  Georgia,  United States; Not yet recruiting
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Idaho
      Site 76, Boise,  Idaho,  United States; Recruiting
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Illinois
      Site 58, Chicago,  Illinois,  United States; Not yet recruiting
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      Site 64, Champaign,  Illinois,  United States; Recruiting
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      Site 72, Chicago,  Illinois,  United States; Recruiting
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      Site 74, Chicago,  Illinois,  United States; Not yet recruiting
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Indiana
      Site 50, Evansville,  Indiana,  United States; Recruiting
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Louisiana
      Site 52, Baton Rouge,  Louisiana,  United States; Recruiting
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      Site 65, Mandeville,  Louisiana,  United States; Recruiting
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      Site 73, Metarie,  Louisiana,  United States; Recruiting
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Maryland
      Site 15, Lutherville,  Maryland,  United States; Not yet recruiting
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      Site 57, Laurel,  Maryland,  United States; Recruiting
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Michigan
      Site 43, Ann Arbor,  Michigan,  United States; Recruiting
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Minnesota
      Site 12, Chaska,  Minnesota,  United States; Not yet recruiting
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Missouri
      Site 3, St. Louis,  Missouri,  United States; Not yet recruiting
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      Site 16, Kansas City,  Missouri,  United States; Not yet recruiting
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      Site 19, Kansas City,  Missouri,  United States; Recruiting
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      Site 80, St. Louis,  Missouri,  United States; Recruiting
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Montana
      Site 17, Billings,  Montana,  United States; Recruiting
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Nebraska
      Site 36, Lincoln,  Nebraska,  United States; Recruiting
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Nevada
      Site 7, Las Vegas,  Nevada,  United States; Recruiting
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      Site 28, Reno,  Nevada,  United States; Recruiting
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North Carolina
      Site 39, New Bern,  North Carolina,  United States; Recruiting
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      Site 46, Winston Salem,  North Carolina,  United States; Recruiting
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      Site 59, Winston Salem,  North Carolina,  United States; Recruiting
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      Site 79, Raleigh,  North Carolina,  United States; Recruiting
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Ohio
      Site 34, Cleveland,  Ohio,  United States; Not yet recruiting
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      Site 45, Cincinnati,  Ohio,  United States; Not yet recruiting
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      Site 53, Columbus,  Ohio,  United States; Recruiting
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      Site 78, Mogadore,  Ohio,  United States; Recruiting
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      Site 81, Cincinnati,  Ohio,  United States; Not yet recruiting
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Oklahoma
      Site 77, Tulsa,  Oklahoma,  United States; Not yet recruiting
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Oregon
      Site 13, Portland,  Oregon,  United States; Recruiting
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      Site 89, Portland,  Oregon,  United States; Recruiting
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Pennsylvania
      Site 63, Pottstown,  Pennsylvania,  United States; Recruiting
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      Site 84, Philadelphia,  Pennsylvania,  United States; Recruiting
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Rhode Island
      Site 22, Warwick,  Rhode Island,  United States; Recruiting
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South Carolina
      Site 24, Greenville,  South Carolina,  United States; Recruiting
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      Site 67, Hilton Head,  South Carolina,  United States; Recruiting
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Tennessee
      Site 10, Chattanooga,  Tennessee,  United States; Recruiting
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      Site 56, Nashville,  Tennessee,  United States; Recruiting
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      Site 88, Memphis,  Tennessee,  United States; Not yet recruiting
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Texas
      Site 11, Houston,  Texas,  United States; Not yet recruiting
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      Site 20, Corpus Christi,  Texas,  United States; Recruiting
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      Site 30, San Antonio,  Texas,  United States; Recruiting
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      Site 41, San Antonio,  Texas,  United States; Recruiting
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      Site 86, Bryan,  Texas,  United States; Recruiting
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Utah
      Site 49, Salt Lake City,  Utah,  United States; Recruiting
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Virginia
      Site 2, Norfolk,  Virginia,  United States; Not yet recruiting
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      Site 29, Richmond,  Virginia,  United States; Recruiting
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      Site 42, Virginia Beach,  Virginia,  United States; Recruiting
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      Site 47, Charlottesville,  Virginia,  United States; Not yet recruiting
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      Site 48, Richmond,  Virginia,  United States; Recruiting
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Washington
      Site 5, Seattle,  Washington,  United States; Recruiting
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      Site 32, Tacoma,  Washington,  United States; Recruiting
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      Site 38, Spokane,  Washington,  United States; Recruiting
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Canada
      Site 108, Saskatoon,  Canada; Not yet recruiting
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      Site 94, Quebec,  Canada; Not yet recruiting
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      Site 97, Quebec,  Canada; Not yet recruiting
See central contact

Canada, British Columbia
      Site 100, North Vancouver,  British Columbia,  Canada; Not yet recruiting
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      Site 116, West Vancouver,  British Columbia,  Canada; Not yet recruiting
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      Site 120, Abbotsford,  British Columbia,  Canada; Not yet recruiting
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Canada, Manitoba
      Site 93, Winnipeg,  Manitoba,  Canada; Not yet recruiting
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      Site 118, Winnipeg,  Manitoba,  Canada; Not yet recruiting
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      Site 122, Winnipeg,  Manitoba,  Canada; Not yet recruiting
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Canada, New Brunswick
      Site 98, Miramichi,  New Brunswick,  Canada; Not yet recruiting
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Canada, Newfoundland and Labrador
      Site 111, St. John’s,  Newfoundland and Labrador,  Canada; Not yet recruiting
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Canada, Ontario
      Site 92, Sarnia,  Ontario,  Canada; Not yet recruiting
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      Site 95, Hamilton,  Ontario,  Canada; Not yet recruiting
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      Site 96, Strathroy,  Ontario,  Canada; Not yet recruiting
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      Site 99, London,  Ontario,  Canada; Not yet recruiting
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      Site 101, Oakville,  Ontario,  Canada; Not yet recruiting
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      Site 102, Oakville,  Ontario,  Canada; Not yet recruiting
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      Site 106, Newmarket,  Ontario,  Canada; Not yet recruiting
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      Site 107, London,  Ontario,  Canada; Not yet recruiting
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      Site 109, Burlington,  Ontario,  Canada; Not yet recruiting
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      Site 113, Sarnia,  Ontario,  Canada; Not yet recruiting
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      Site 114, Toronto,  Ontario,  Canada; Not yet recruiting
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      Site 115, Kingston,  Ontario,  Canada; Not yet recruiting
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      Site 117, Peterborough,  Ontario,  Canada; Not yet recruiting
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      Site 121, Woodstock,  Ontario,  Canada; Not yet recruiting
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Canada, Quebec
      Site 91, Shawinigan,  Quebec,  Canada; Not yet recruiting
See central contact

      Site 103, Rimouski,  Quebec,  Canada; Not yet recruiting
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      Site 104, Montreal,  Quebec,  Canada; Not yet recruiting
See central contact

      Site 105, Sherbrooke,  Quebec,  Canada; Not yet recruiting
See central contact

      Site 110, Greenfield,  Quebec,  Canada; Not yet recruiting
See central contact

      Site 112, Montreal,  Quebec,  Canada; Not yet recruiting
See central contact

      Site 119, Sainte-Foy,  Quebec,  Canada; Not yet recruiting
See central contact

Russian Federation
      Site 123, St Petersburg,  Russian Federation; Not yet recruiting
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      Site 124, Moscow,  Russian Federation; Not yet recruiting
See central contact

      Site 125, Moscow,  Russian Federation; Not yet recruiting
See central contact

      Site 126, Moscow,  Russian Federation; Not yet recruiting
See central contact

      Site 127, St Petersburg,  Russian Federation; Not yet recruiting
See central contact

      Site 128, Moscow,  Russian Federation; Not yet recruiting
See central contact

      Site 129, Moscow,  Russian Federation; Not yet recruiting
See central contact

      Site 130, Moscow,  Russian Federation; Not yet recruiting
See central contact

      Site 131, St Petersburg,  Russian Federation; Not yet recruiting
See central contact

      Site 132, Moscow,  Russian Federation; Not yet recruiting
See central contact

      Site 133, Moscow,  Russian Federation; Not yet recruiting
See central contact

      Site 134, St Petersburg,  Russian Federation; Not yet recruiting
See central contact

Study chairs or principal investigators

Global Clinical Director Solvay,  Study Director,  Solvay Pharmaceuticals   

More Information

Study ID Numbers:  S030.2.112; 2005-002887-27
Last Updated:  September 11, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00160342
Health Authority: United States: Food and Drug Administration; Canada: Health Canada; Russia: Pharmacological Committee, Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005

Resources

  • (National Women's Health Information Center, OWH, HHS)
  • (National Women's Health Information Center, OWH, HHS)


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