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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00141544
First received: August 30, 2005
Last updated: April 10, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Menopause
Drug: esterified estrogens 1.25 mg and methyltestosterone 2.5 mg
Drug: Esterified estrogens 1.25 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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) [ 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: 28
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
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

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141544

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

No publications provided

Responsible Party: Cindy Lane, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00141544     History of Changes
Other Study ID Numbers: S030.2.107
Study First Received: August 30, 2005
Last Updated: April 10, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 26, 2014