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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Solvay Pharmaceuticals

Current Primary Outcome: Change from baseline in the total score of the Menopause Rating Scale (MRS) [ Time Frame: 12 weeks ]

Original Primary Outcome:

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

Information By: Solvay Pharmaceuticals

Dates:
Date Received: August 30, 2005
Date Started: July 2004
Date Completion:
Last Updated: April 10, 2008
Last Verified: April 2008