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

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ClinicalTrials.gov Identifier: NCT00141544
Recruitment Status : Terminated (Lack of enrollment)
First Posted : September 1, 2005
Last Update Posted : April 11, 2008
Sponsor:
Information provided by:
Solvay Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Menopause Drug: esterified estrogens 1.25 mg and methyltestosterone 2.5 mg Drug: Esterified estrogens 1.25 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women
Study Start Date : July 2004
Primary Completion Date : April 2007
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: esterified estrogens 1.25 mg and methyltestosterone 2.5 mg
ESTRATEST® administered orally QD
Active Comparator: 2 Drug: Esterified estrogens 1.25 mg
Esterified estrogens 1.25 mg administered orally QD



Primary Outcome Measures :
  1. Change from baseline in the total score of the Menopause Rating Scale (MRS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in the domain and individual item scores of the MRS [ Time Frame: 12 weeks ]
  2. Change from baseline in the domain scores of the MENQOL [ Time Frame: monthly for 3 months ]
  3. Comparison of changes in hormone levels and correlation with changes in the MRS [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Non-hysterectomized, menopausal women between the ages of 35 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


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): NCT00141544


  Show 78 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Responsible Party: Cindy Lane, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00141544     History of Changes
Other Study ID Numbers: S030.2.107
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: April 11, 2008
Last Verified: April 2008

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

Additional relevant MeSH terms:
Estrogens
Estrogens, Esterified (USP)
Estrone
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