Official Title: “A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women”

This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2007

Intervention(s) in this Clinical Trial

• Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
  • oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
• Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
  • oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
• Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
  • oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
• Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
  • oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
• Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
  • oral tablet, QD, 12 weeks, 0.30 EE
• Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
  • oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
• Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
  • oral tablet, QD, 12 weeks, 0.45 EE
• Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
  • oral tablet, QD, 12 weeks, 0.60 MT
• Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)
  • oral tablet, QD, 12 weeks, Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Experimental: 2
• Experimental: 3
• Active Comparator: 4
• Experimental: 5
• Experimental: 6
• Active Comparator: 7
• Active Comparator: 8
• Placebo Comparator: 9

Primary Measures

• Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4
  • Time Frame: 4 weeks
    Safety Issue?: No
• Mean change in frequency of moderate to severe VMS from baseline to Week 12
  • Time Frame: 12 weeks
    Safety Issue?: No
• Mean change in severity of moderate to severe VMS from baseline to Week 4
  • Time Frame: 4 weeks
    Safety Issue?: No
• Mean change in severity of moderate to severe VMS from baseline to Week 12
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Frequency and severity of moderate to severe and all hot flushes at each week
  • Time Frame: 12 weeks
    Safety Issue?: No
• Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome
  • Time Frame: 12 weeks
    Safety Issue?: No
• Mean change from baseline to Week 12 in vaginal pH
  • Time Frame: 12 weeks
    Safety Issue?: No
• Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. Be able to communicate with the Investigator and study staff and be able to complete the required study procedures, 2. Be a female of any race between the ages of 45-65 years, in generally good health, 3. Be either naturally or surgically postmenopausal (with or without a uterus)

Exclusion Criteria:

• 1. Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins, 2. History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Solvay Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00160342

Study ID Number: S030.2.112

ClinicalTrials.gov Identifier: NCT00160342

Health Authority: United States: Food and Drug Administration