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The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women
This study has been terminated.
( Lack of enrollment )
First Received: August 30, 2005   Last Updated: April 10, 2008   History of Changes
Sponsor: Solvay Pharmaceuticals
Information provided by: Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00141557
  Purpose

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


Condition Intervention Phase
Menopause
Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg
Drug: Esterified estrogens 1.25 mg
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in the total score of the Menopause Rating Scale (MRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 133
Study Start Date: July 2004
Study Completion Date: March 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg
ESTRATEST® administered orally QD
2: Active Comparator Drug: Esterified estrogens 1.25 mg
Esterified estrogens 1.25 mg administered orally QD

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141557

  Show 78 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Solvay Pharmaceuticals ( Cindy Lane )
Study ID Numbers: S030.2.110
Study First Received: August 30, 2005
Last Updated: April 10, 2008
ClinicalTrials.gov Identifier: NCT00141557     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Menopause; Postmenopause; Estrogen; Hormone Therapy

Additional relevant MeSH terms:
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Hormones
Pharmacologic Actions
Testosterone 17 beta-cypionate
Estrogens, Esterified (USP)
Testosterone
Anabolic Agents
Therapeutic Uses
Androgens
Estrone

ClinicalTrials.gov processed this record on February 08, 2010