Trial record 21 of 23 for:
Estropipate
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00141557 |
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Recruitment Status :
Terminated
(Lack of enrollment)
First Posted : September 1, 2005
Last Update Posted : April 11, 2008
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Sponsor:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
- Study Details
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Brief Summary:
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Menopause | Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg Drug: Esterified estrogens 1.25 mg | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 133 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women |
| Study Start Date : | July 2004 |
| Actual Primary Completion Date : | April 2007 |
| Actual Study Completion Date : | March 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Menopause
Drug Information available for:
Estrogens
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg
ESTRATEST® administered orally QD |
| Active Comparator: 2 |
Drug: Esterified estrogens 1.25 mg
Esterified estrogens 1.25 mg administered orally QD |
Primary Outcome Measures :
- Change from baseline in the total score of the Menopause Rating Scale (MRS) [ Time Frame: 12 weeks ]
Secondary Outcome Measures :
- Change from baseline in the domain and individual item scores of the MRS [ Time Frame: 12 weeks ]
- Change from baseline in the domain scores of the MENQOL [ Time Frame: monthly for 3 months ]
- Comparison of changes in hormone levels and correlation with changes in the MRS [ Time Frame: 12 weeks ]
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| Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Hysterectomized, menopausal women between the ages of 30 and 65 years of age (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141557
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Locations
| United States, Alabama | |
| Site 66 | |
| Huntsville, Alabama, United States | |
| Site 57 | |
| Mobile, Alabama, United States | |
| Site 46 | |
| Montgomery, Alabama, United States | |
| United States, Arizona | |
| Site 29 | |
| Phoenix, Arizona, United States | |
| Site 15 | |
| Tucson, Arizona, United States | |
| United States, Arkansas | |
| Site 3 | |
| Jonesboro, Arkansas, United States | |
| Site 22 | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| Site 68 | |
| Carmichael, California, United States | |
| Site 55 | |
| Encinitas, California, United States | |
| Site 6 | |
| San Diego, California, United States | |
| Site 45 | |
| Santa Rosa, California, United States | |
| Site 25 | |
| Walnut Creek, California, United States | |
| United States, Colorado | |
| Site 26 | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| Site 1 | |
| Groton, Connecticut, United States | |
| Site 54 | |
| Hartford, Connecticut, United States | |
| Site 30 | |
| Trumbull, Connecticut, United States | |
| Site 34 | |
| Waterbury, Connecticut, United States | |
| United States, Florida | |
| Site 10 | |
| Aventura, Florida, United States | |
| Site 78 | |
| Clearwater, Florida, United States | |
| Site 73 | |
| Ft. Myers, Florida, United States | |
| Site 51 | |
| Leesburg, Florida, United States | |
| Site 49 | |
| Melbourne, Florida, United States | |
| Site 64 | |
| New Port Richey, Florida, United States | |
| Site 61 | |
| Ocala, Florida, United States | |
| Site 27 | |
| Palm Springs, Florida, United States | |
| Site 11 | |
| Pinellas Park, Florida, United States | |
| Site 75 | |
| Sarasota, Florida, United States | |
| Site 69 | |
| St. Petersburg, Florida, United States | |
| Site 70 | |
| Venice, Florida, United States | |
| Site 17 | |
| West Palm Beach, Florida, United States | |
| United States, Georgia | |
| Site 50 | |
| Alpharetta, Georgia, United States | |
| Site 5 | |
| Atlanta, Georgia, United States | |
| Site 44 | |
| Decatur, Georgia, United States | |
| Site 77 | |
| Douglasville, Georgia, United States | |
| Site 9 | |
| Riverdale, Georgia, United States | |
| Site 7 | |
| Savannah, Georgia, United States | |
| United States, Idaho | |
| Site 47 | |
| Boise, Idaho, United States | |
| United States, Illinois | |
| Site 24 | |
| Champaign, Illinois, United States | |
| Site 20 | |
| Chicago, Illinois, United States | |
| Site 76 | |
| Peoria, Illinois, United States | |
| United States, Indiana | |
| Site 58 | |
| Evansville, Indiana, United States | |
| United States, Kansas | |
| Site 39 | |
| Wichita, Kansas, United States | |
| United States, Louisiana | |
| Site 59 | |
| Baton Rouge, Louisiana, United States | |
| Site 52 | |
| New Orleans, Louisiana, United States | |
| United States, Michigan | |
| Site 53 | |
| Ann Arbor, Michigan, United States | |
| United States, Missouri | |
| Site 63 | |
| Kansas City, Missouri, United States | |
| Site 32 | |
| Richmond Heights, Missouri, United States | |
| Site 36 | |
| St. Louis, Missouri, United States | |
| United States, Montana | |
| Site 72 | |
| Billings, Montana, United States | |
| United States, Nebraska | |
| Site 21 | |
| Lincoln, Nebraska, United States | |
| United States, Nevada | |
| Site 37 | |
| Reno, Nevada, United States | |
| United States, North Carolina | |
| Site 65 | |
| Cary, North Carolina, United States | |
| Site 13 | |
| New Bern, North Carolina, United States | |
| Site 16 | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| Site 60 | |
| Columbus, Ohio, United States | |
| United States, Oklahoma | |
| Site 67 | |
| Oklahoma City, Oklahoma, United States | |
| Site 40 | |
| Tulsa, Oklahoma, United States | |
| United States, Oregon | |
| Site 62 | |
| Eugene, Oregon, United States | |
| Site 41 | |
| Medford, Oregon, United States | |
| Site 33 | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Site 18 | |
| Erie, Pennsylvania, United States | |
| Site 19 | |
| Philadelphia, Pennsylvania, United States | |
| Site 23 | |
| Pottstown, Pennsylvania, United States | |
| United States, South Carolina | |
| Site 31 | |
| Anderson, South Carolina, United States | |
| Site 35 | |
| Greer, South Carolina, United States | |
| United States, Tennessee | |
| Site 4 | |
| Chattanooga, Tennessee, United States | |
| United States, Texas | |
| Site 74 | |
| Conroe, Texas, United States | |
| Site 8 | |
| Corpus Christi, Texas, United States | |
| Site 71 | |
| Dallas, Texas, United States | |
| Site 42 | |
| Houston, Texas, United States | |
| Site 14 | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| Site 38 | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Site 28 | |
| Norfolk, Virginia, United States | |
| Site 12 | |
| Richmond, Virginia, United States | |
| United States, Washington | |
| Site 56 | |
| Renton, Washington, United States | |
| Site 2 | |
| Seattle, Washington, United States | |
| Site 48 | |
| Spokane, Washington, United States | |
| Site 43 | |
| Tacoma, Washington, United States | |
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
| Responsible Party: | Cindy Lane, Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00141557 History of Changes |
| Other Study ID Numbers: |
S030.2.110 |
| First Posted: | September 1, 2005 Key Record Dates |
| Last Update Posted: | April 11, 2008 |
| Last Verified: | April 2008 |
Keywords provided by Solvay Pharmaceuticals:
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Menopause; Postmenopause; Estrogen; Hormone Therapy |
Additional relevant MeSH terms:
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Estrone Methyltestosterone Estrogens Estrogens, Esterified (USP) Testosterone Testosterone undecanoate Testosterone enanthate Testosterone 17 beta-cypionate |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents Androgens |