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Trial record 21 of 23 for:    Estropipate

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00141557
Recruitment Status : Terminated (Lack of enrollment)
First Posted : September 1, 2005
Last Update Posted : April 11, 2008
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE September 1, 2005
Last Update Posted Date April 11, 2008
Study Start Date  ICMJE July 2004
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Change from baseline in the total score of the Menopause Rating Scale (MRS) [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00141557 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • Change from baseline in the domain and individual item scores of the MRS [ Time Frame: 12 weeks ]
  • Change from baseline in the domain scores of the MENQOL [ Time Frame: monthly for 3 months ]
  • Comparison of changes in hormone levels and correlation with changes in the MRS [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Menopause
Intervention  ICMJE
  • Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg
    ESTRATEST® administered orally QD
  • Drug: Esterified estrogens 1.25 mg
    Esterified estrogens 1.25 mg administered orally QD
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg
  • Active Comparator: 2
    Intervention: Drug: Esterified estrogens 1.25 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 10, 2008)
133
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2008
Actual 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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141557
Other Study ID Numbers  ICMJE S030.2.110
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cindy Lane, Solvay Pharmaceuticals
Study Sponsor  ICMJE Solvay Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
PRS Account Solvay Pharmaceuticals
Verification Date April 2008

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