Official Title: “A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens, A (Cenestin) for the Treatment of Vasomotor Symptoms in Postmenopausal Women”

This is a randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.

Study Type: Interventional

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

Study Primary Completion Date: May 2007

The overall study duration will be approximately 16 weeks. After a screening/baseline period of up to 4 weeks patients will be randomized to receive either placebo tablets or Cenestin 0.3mg tablets

Intervention(s) in this Clinical Trial

• Drug: Cenestin 0.3 mg Tablets
  • 1 tablet daily
• Other: Placebo
  • 1 tablet daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Mean change in average frequency of moderate to severe hot flashes
  • Time Frame: Baseline to Day 28 and to Day 84
    Safety Issue?: No
• Mean change in severity of moderate to severe hot flashes
  • Time Frame: Baseline to Day 28 and to Day 84
    Safety Issue?: No

Secondary Measures

• Safety and tolerability of Cenestin 0.3mg
  • Time Frame: Throughout study
    Safety Issue?: Yes

Inclusion Criteria:

• Naturally or surgically postmenopausal
• At least 12 months since last menses or 6 weeks past surgery
• Minimum of 7 daily or 50 weekly moderate to severe hot flashes

Exclusion Criteria:

• Any contraindication to natural or synthetic estrogens

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Duramed Research Medical Monitor Principal Investigator Duramed Research  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00272935

Study ID Number: BR-CEN-301

ClinicalTrials.gov Identifier: NCT00272935

Health Authority: United States: Food and Drug Administration

NIH - Postmenopausal Hormone Therapy