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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00141544
First received: August 30, 2005
Last updated: April 10, 2008
Last verified: April 2008

August 30, 2005
April 10, 2008
July 2004
April 2007   (final data collection date for primary outcome measure)
Change from baseline in the total score of the Menopause Rating Scale (MRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00141544 on ClinicalTrials.gov Archive Site
  • Change from baseline in the domain and individual item scores of the MRS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the domain scores of the MENQOL [ Time Frame: monthly for 3 months ] [ Designated as safety issue: No ]
  • Comparison of changes in hormone levels and correlation with changes in the MRS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Menopause
  • Drug: esterified estrogens 1.25 mg and methyltestosterone 2.5 mg
    ESTRATEST® administered orally QD
  • Drug: Esterified estrogens 1.25 mg
    Esterified estrogens 1.25 mg administered orally QD
  • Experimental: 1
    Intervention: Drug: esterified estrogens 1.25 mg and methyltestosterone 2.5 mg
  • Active Comparator: 2
    Intervention: Drug: Esterified estrogens 1.25 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
28
March 2008
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

Non-hysterectomized, menopausal women between the ages of 35 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

Female
35 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00141544
S030.2.107
No
Cindy Lane, Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP