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TerminatedNCT00141557Updated Apr 11, 2008

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

A Phase 2 interventional study of esterified estrogens 1.25mg and methyltestosterone 2.5mg and Esterified estrogens 1.25 mg in Menopause, sponsored by Solvay Pharmaceuticals. Terminated at 78 sites in United States. Open to female participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-04-11.

Sponsored by Solvay Pharmaceuticals · Phase 2, Interventional, and Treatment

Why this study was terminated
Lack of enrollment
Phase
Phase 2
Study type
Interventional
Enrollment
133
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Menopause

Keywords

  • Menopause; Postmenopause; Estrogen; Hormone Therapy
03

In context

Lead sponsor

Solvay Pharmaceuticals is the lead sponsor of 84 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility 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

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
133 participants (actual)

Study arms

  • Experimental
    1

    Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg

  • Active comparator
    2

    Drug: Esterified estrogens 1.25 mg

Interventions

  • Drugesterified estrogens 1.25mg and methyltestosterone 2.5mg

    ESTRATEST® administered orally QD

  • DrugEsterified estrogens 1.25 mg

    Esterified estrogens 1.25 mg administered orally QD

06

What researchers measure

Primary outcomes

  1. Change from baseline in the total score of the Menopause Rating Scale (MRS)

    Time frame: 12 weeks

Secondary outcomes

  1. Change from baseline in the domain and individual item scores of the MRS

    Time frame: 12 weeks

  2. Change from baseline in the domain scores of the MENQOL

    Time frame: monthly for 3 months

  3. Comparison of changes in hormone levels and correlation with changes in the MRS

    Time frame: 12 weeks

07

Study locations

78 sites
  • Site 66
    Huntsville, Alabama, United States
  • Site 57
    Mobile, Alabama, United States
  • Site 46
    Montgomery, Alabama, United States
  • Site 29
    Phoenix, Arizona, United States
  • Site 15
    Tucson, Arizona, United States
  • Site 3
    Jonesboro, Arkansas, United States
  • Site 22
    Little Rock, Arkansas, United States
  • 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
  • Site 26
    Denver, Colorado, United States
  • Site 1
    Groton, Connecticut, United States
  • Site 54
    Hartford, Connecticut, United States
  • Site 30
    Trumbull, Connecticut, United States
  • Site 34
    Waterbury, Connecticut, United States
  • 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
  • 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
  • Site 47
    Boise, Idaho, United States
  • Site 24
    Champaign, Illinois, United States
  • Site 20
    Chicago, Illinois, United States
  • Site 76
    Peoria, Illinois, United States
  • Site 58
    Evansville, Indiana, United States
  • Site 39
    Wichita, Kansas, United States
  • Site 59
    Baton Rouge, Louisiana, United States
  • Site 52
    New Orleans, Louisiana, United States
  • Site 53
    Ann Arbor, Michigan, United States
  • Site 63
    Kansas City, Missouri, United States
  • Site 32
    Richmond Heights, Missouri, United States
  • Site 36
    St. Louis, Missouri, United States
  • Site 72
    Billings, Montana, United States
  • Site 21
    Lincoln, Nebraska, United States
  • Site 37
    Reno, Nevada, United States
  • Site 65
    Cary, North Carolina, United States
  • Site 13
    New Bern, North Carolina, United States
  • Site 16
    Winston-Salem, North Carolina, United States
  • Site 60
    Columbus, Ohio, United States
  • Site 67
    Oklahoma City, Oklahoma, United States
  • Site 40
    Tulsa, Oklahoma, United States
  • Site 62
    Eugene, Oregon, United States
  • Site 41
    Medford, Oregon, United States
  • Site 33
    Portland, Oregon, United States
  • Site 18
    Erie, Pennsylvania, United States
  • Site 19
    Philadelphia, Pennsylvania, United States
  • Site 23
    Pottstown, Pennsylvania, United States
  • Site 31
    Anderson, South Carolina, United States
  • Site 35
    Greer, South Carolina, United States
  • Site 4
    Chattanooga, Tennessee, United States
  • 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
  • Site 38
    Salt Lake City, Utah, United States
  • Site 28
    Norfolk, Virginia, United States
  • Site 12
    Richmond, Virginia, United States
  • Site 56
    Renton, Washington, United States
  • Site 2
    Seattle, Washington, United States
  • Site 48
    Spokane, Washington, United States
  • Site 43
    Tacoma, Washington, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00141557
Lead sponsor
Solvay Pharmaceuticals
First posted
Sep 1, 2005
Start date
Jul 2004
Primary completion
Apr 2007
Completion
Mar 2008
Last update
Apr 11, 2008

Study contacts

Global Clinical Director Solvay
study director · Solvay Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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