A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes

Verified by: Duramed Research, July 2009
First Received: January 4, 2006 | Last Updated: January 8, 2010 | Phase: Phase 3 | Start Date: December 2005
Overall Status: Completed | Estimated Enrollment: 400
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2007

Detailed Clinical Trial Description

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Duramed Research Industry

Overall Clinical Trial Officials and Contacts

Duramed Research Protocol Chair Study Chair Duramed Research, Inc  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00272935