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

Tracking Information

First Received Date ^ICMJE

August 30, 2005

Last Updated Date

April 10, 2008

Start Date ^ICMJE

July 2004

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12

Change History

Complete list of historical versions of study NCT00141557 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Change from baseline in the MRS at Week 12 & monthly change from baseline to Week 12 in the MENQOL; Comparison of changes in SHBG & testosterone & how these changes correlate with the MRS

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Menopause

Intervention ^ICMJE

Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg
Drug: Esterified estrogens 1.25 mg

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

133

Completion Date

March 2008

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

35 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00141557

Responsible Party

Cindy Lane, Solvay Pharmaceuticals

Study ID Numbers ^ICMJE

S030.2.110

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

April 2008

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