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

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

MedlinePlus related topics:

Menopause

ChemIDplus related topics:

Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

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

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

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

Keywords provided by Solvay Pharmaceuticals:

Menopause; Postmenopause; Estrogen; Hormone Therapy

Study placed in the following topic categories:

Estrogens, Esterified (USP)

Testosterone

Estropipate

Methyltestosterone

Menopause

Estrone

Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Estrogens

Anabolic Agents

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Hormones

Pharmacologic Actions

Androgens

ClinicalTrials.gov processed this record on July 18, 2008

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00141557