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Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141570
First Posted: September 1, 2005
Last Update Posted: January 16, 2015
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.
Information provided by:
Solvay Pharmaceuticals
  Purpose
To determine whether treatment with ESTRATEST® H.S. Tablets is superior to treatment with esterified estrogens tablets

Condition Intervention Phase
Menopause Drug: esterified estrogens 0.625 mg and methyltestosterone 1.25 mg Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized 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) at Week 12

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 350
Study Start Date: June 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Menopausal women between the ages of 30 and 65 years (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141570


  Show 77 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

ClinicalTrials.gov Identifier: NCT00141570     History of Changes
Other Study ID Numbers: S030.2.106
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: January 16, 2015
Last Verified: January 2009

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

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