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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00141570
First received: August 30, 2005
Last updated: January 29, 2009
Last verified: January 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders 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
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: NCT00141570

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

No publications provided

ClinicalTrials.gov Identifier: NCT00141570     History of Changes
Other Study ID Numbers: S030.2.106
Study First Received: August 30, 2005
Last Updated: January 29, 2009
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Androgens

ClinicalTrials.gov processed this record on October 16, 2014