The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women

NCT ID: NCT00141557

Last Updated: 2008-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-03-31

Brief Summary

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To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets

Detailed Description

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Conditions

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Menopause

Keywords

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Menopause; Postmenopause; Estrogen; Hormone Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

esterified estrogens 1.25mg and methyltestosterone 2.5mg

Intervention Type DRUG

ESTRATEST® administered orally QD

2

Group Type ACTIVE_COMPARATOR

Esterified estrogens 1.25 mg

Intervention Type DRUG

Esterified estrogens 1.25 mg administered orally QD

Interventions

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esterified estrogens 1.25mg and methyltestosterone 2.5mg

ESTRATEST® administered orally QD

Intervention Type DRUG

Esterified estrogens 1.25 mg

Esterified estrogens 1.25 mg administered orally QD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 66

Huntsville, Alabama, United States

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Site 57

Mobile, Alabama, United States

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Site 46

Montgomery, Alabama, United States

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Site 29

Phoenix, Arizona, United States

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Site 15

Tucson, Arizona, United States

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Site 3

Jonesboro, Arkansas, United States

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Site 22

Little Rock, Arkansas, United States

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Site 68

Carmichael, California, United States

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Site 55

Encinitas, California, United States

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Site 6

San Diego, California, United States

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Site 45

Santa Rosa, California, United States

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Site 25

Walnut Creek, California, United States

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Site 26

Denver, Colorado, United States

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Site 1

Groton, Connecticut, United States

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Site 54

Hartford, Connecticut, United States

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Site 30

Trumbull, Connecticut, United States

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Site 34

Waterbury, Connecticut, United States

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Site 10

Aventura, Florida, United States

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Site 78

Clearwater, Florida, United States

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Site 73

Fort Myers, Florida, United States

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Site 51

Leesburg, Florida, United States

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Site 49

Melbourne, Florida, United States

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Site 64

New Port Richey, Florida, United States

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Site 61

Ocala, Florida, United States

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Site 27

Palm Springs, Florida, United States

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Site 11

Pinellas Park, Florida, United States

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Site 75

Sarasota, Florida, United States

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Site 69

St. Petersburg, Florida, United States

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Site 70

Venice, Florida, United States

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Site 17

West Palm Beach, Florida, United States

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Site 50

Alpharetta, Georgia, United States

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Site 5

Atlanta, Georgia, United States

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Site 44

Decatur, Georgia, United States

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Site 77

Douglasville, Georgia, United States

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Site 9

Riverdale, Georgia, United States

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Site 7

Savannah, Georgia, United States

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Site 47

Boise, Idaho, United States

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Site 24

Champaign, Illinois, United States

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Site 20

Chicago, Illinois, United States

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Site 76

Peoria, Illinois, United States

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Site 58

Evansville, Indiana, United States

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Site 39

Wichita, Kansas, United States

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Site 59

Baton Rouge, Louisiana, United States

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Site 52

New Orleans, Louisiana, United States

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Site 53

Ann Arbor, Michigan, United States

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Site 63

Kansas City, Missouri, United States

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Site 32

Richmond Heights, Missouri, United States

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Site 36

St Louis, Missouri, United States

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Site 72

Billings, Montana, United States

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Site 21

Lincoln, Nebraska, United States

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Site 37

Reno, Nevada, United States

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Site 65

Cary, North Carolina, United States

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Site 13

New Bern, North Carolina, United States

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Site 16

Winston-Salem, North Carolina, United States

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Site 60

Columbus, Ohio, United States

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Site 67

Oklahoma City, Oklahoma, United States

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Site 40

Tulsa, Oklahoma, United States

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Site 62

Eugene, Oregon, United States

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Site 41

Medford, Oregon, United States

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Site 33

Portland, Oregon, United States

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Site 18

Erie, Pennsylvania, United States

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Site 19

Philadelphia, Pennsylvania, United States

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Site 23

Pottstown, Pennsylvania, United States

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Site 31

Anderson, South Carolina, United States

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Site 35

Greer, South Carolina, United States

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Site 4

Chattanooga, Tennessee, United States

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Site 74

Conroe, Texas, United States

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Site 8

Corpus Christi, Texas, United States

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Site 71

Dallas, Texas, United States

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Site 42

Houston, Texas, United States

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Site 14

San Antonio, Texas, United States

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Site 38

Salt Lake City, Utah, United States

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Site 28

Norfolk, Virginia, United States

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Site 12

Richmond, Virginia, United States

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Site 56

Renton, Washington, United States

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Site 2

Seattle, Washington, United States

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Site 48

Spokane, Washington, United States

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Site 43

Tacoma, Washington, United States

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Countries

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United States

Other Identifiers

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S030.2.110

Identifier Type: -

Identifier Source: org_study_id