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

A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women

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

Study Overview

• Status: Terminated
• Conditions: Menopause
• Intervention / Treatment: Drug: Esterified estrogens 1.25 mg; Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States
      • Site 66
    • Mobile, Alabama, United States
      • Site 57
    • Montgomery, Alabama, United States
      • Site 46
  • Arizona
    • Phoenix, Arizona, United States
      • Site 29
    • Tucson, Arizona, United States
      • Site 15
  • Arkansas
    • Jonesboro, Arkansas, United States
      • Site 3
    • Little Rock, Arkansas, United States
      • Site 22
  • California
    • Carmichael, California, United States
      • Site 68
    • Encinitas, California, United States
      • Site 55
    • San Diego, California, United States
      • Site 6
    • Santa Rosa, California, United States
      • Site 45
    • Walnut Creek, California, United States
      • Site 25
  • Colorado
    • Denver, Colorado, United States
      • Site 26
  • Connecticut
    • Groton, Connecticut, United States
      • Site 1
    • Hartford, Connecticut, United States
      • Site 54
    • Trumbull, Connecticut, United States
      • Site 30
    • Waterbury, Connecticut, United States
      • Site 34
  • Florida
    • Aventura, Florida, United States
      • Site 10
    • Clearwater, Florida, United States
      • Site 78
    • Ft. Myers, Florida, United States
      • Site 73
    • Leesburg, Florida, United States
      • Site 51
    • Melbourne, Florida, United States
      • Site 49
    • New Port Richey, Florida, United States
      • Site 64
    • Ocala, Florida, United States
      • Site 61
    • Palm Springs, Florida, United States
      • Site 27
    • Pinellas Park, Florida, United States
      • Site 11
    • Sarasota, Florida, United States
      • Site 75
    • St. Petersburg, Florida, United States
      • Site 69
    • Venice, Florida, United States
      • Site 70
    • West Palm Beach, Florida, United States
      • Site 17
  • Georgia
    • Alpharetta, Georgia, United States
      • Site 50
    • Atlanta, Georgia, United States
      • Site 5
    • Decatur, Georgia, United States
      • Site 44
    • Douglasville, Georgia, United States
      • Site 77
    • Riverdale, Georgia, United States
      • Site 9
    • Savannah, Georgia, United States
      • Site 7
  • Idaho
    • Boise, Idaho, United States
      • Site 47
  • Illinois
    • Champaign, Illinois, United States
      • Site 24
    • Chicago, Illinois, United States
      • Site 20
    • Peoria, Illinois, United States
      • Site 76
  • Indiana
    • Evansville, Indiana, United States
      • Site 58
  • Kansas
    • Wichita, Kansas, United States
      • Site 39
  • Louisiana
    • Baton Rouge, Louisiana, United States
      • Site 59
    • New Orleans, Louisiana, United States
      • Site 52
  • Michigan
    • Ann Arbor, Michigan, United States
      • Site 53
  • Missouri
    • Kansas City, Missouri, United States
      • Site 63
    • Richmond Heights, Missouri, United States
      • Site 32
    • St. Louis, Missouri, United States
      • Site 36
  • Montana
    • Billings, Montana, United States
      • Site 72
  • Nebraska
    • Lincoln, Nebraska, United States
      • Site 21
  • Nevada
    • Reno, Nevada, United States
      • Site 37
  • North Carolina
    • Cary, North Carolina, United States
      • Site 65
    • New Bern, North Carolina, United States
      • Site 13
    • Winston-Salem, North Carolina, United States
      • Site 16
  • Ohio
    • Columbus, Ohio, United States
      • Site 60
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Site 67
    • Tulsa, Oklahoma, United States
      • Site 40
  • Oregon
    • Eugene, Oregon, United States
      • Site 62
    • Medford, Oregon, United States
      • Site 41
    • Portland, Oregon, United States
      • Site 33
  • Pennsylvania
    • Erie, Pennsylvania, United States
      • Site 18
    • Philadelphia, Pennsylvania, United States
      • Site 19
    • Pottstown, Pennsylvania, United States
      • Site 23
  • South Carolina
    • Anderson, South Carolina, United States
      • Site 31
    • Greer, South Carolina, United States
      • Site 35
  • Tennessee
    • Chattanooga, Tennessee, United States
      • Site 4
  • Texas
    • Conroe, Texas, United States
      • Site 74
    • Corpus Christi, Texas, United States
      • Site 8
    • Dallas, Texas, United States
      • Site 71
    • Houston, Texas, United States
      • Site 42
    • San Antonio, Texas, United States
      • Site 14
  • Utah
    • Salt Lake City, Utah, United States
      • Site 38
  • Virginia
    • Norfolk, Virginia, United States
      • Site 28
    • Richmond, Virginia, United States
      • Site 12
  • Washington
    • Renton, Washington, United States
      • Site 56
    • Seattle, Washington, United States
      • Site 2
    • Spokane, Washington, United States
      • Site 48
    • Tacoma, Washington, United States
      • Site 43

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the total score of the Menopause Rating Scale (MRS)	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the domain and individual item scores of the MRS	12 weeks
Change from baseline in the domain scores of the MENQOL	monthly for 3 months
Comparison of changes in hormone levels and correlation with changes in the MRS	12 weeks

Collaborators and Investigators

• Sponsor: Solvay Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: August 30, 2005
• First Submitted That Met QC Criteria: August 30, 2005
• First Posted (Estimate): September 1, 2005

Study Record Updates

• Last Update Posted (Estimate): April 11, 2008
• Last Update Submitted That Met QC Criteria: April 10, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: Menopause; Postmenopause; Estrogen; Hormone Therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Estrogens; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Estrogens, Esterified (USP); Estrone
• Other Study ID Numbers: S030.2.110