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

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:

MedlinePlus related topics: Menopause

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

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