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Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

Phase 2
Completed
Conditions
Menopause
Registration Number
NCT00141570
Lead Sponsor
Solvay Pharmaceuticals
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
350
Inclusion Criteria

Menopausal women between the ages of 30 and 65 years (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

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12
Secondary Outcome Measures
NameTimeMethod
Change from baseline in the MRS at Week 12 & monthly change from baseline to Week 12 in the MENQOL; Comparison of changes in SHBG & testosterone & how these changes correlate with the MRS

Trial Locations

Locations (77)

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

Scroll for more (67 remaining)
Site 66
🇺🇸Huntsville, Alabama, United States

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