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

June 29, 2012 updated by: Duramed Research

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Duramed Investigational Site
      • Montgomery, Alabama, United States, 36116
        • Duramed Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Duramed Investigational Site
      • Phoenix, Arizona, United States, 85032
        • Duramed Investigational Site
      • Tucson, Arizona, United States, 85712
        • Duramed Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • Duramed Investigational Site
      • Irvine, California, United States, 92618
        • Duramed Investigational Site
      • San Diego, California, United States, 92103
        • Duramed Investigational Site
      • San Diego, California, United States, 92123
        • Duramed Investigational Site
      • San Diego, California, United States, 72108
        • Duramed Investigational Site
      • San Ramon, California, United States, 94583
        • Duramed Investigational Site
    • Florida
      • Brooksville, Florida, United States, 34613
        • Duramed Investigational Site
      • Coral Gables, Florida, United States, 33134
        • Duramed Investigational Site
      • Gainesville, Florida, United States, 32607
        • Duramed Investigational Site
      • Leesburg, Florida, United States, 34748
        • Duramed Investigational Site
      • Miami, Florida, United States, 33143
        • Duramed Investigational Site
      • Palm Springs, Florida, United States, 33461
        • Duramed Investigational Site
      • Venice, Florida, United States, 34285
        • Duramed Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Duramed Investigational Site
      • Douglasville, Georgia, United States, 30134
        • Duramed Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83712
        • Duramed Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Duramed Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Duramed Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Duramed Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Duramed Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Duramed Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Duramed Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Duramed Investigational Site
      • Columbus, Ohio, United States, 43213
        • Duramed Investigational Site
      • Mayfield Heights, Ohio, United States, 44124
        • Duramed Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Duramed Investigational Site
    • Pennsylvania
      • King of Prussia, Pennsylvania, United States, 19406
        • Duramed Investigational Site
      • North Wales, Pennsylvania, United States, 19454
        • Duramed Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Duramed Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Duramed Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15206
        • Duramed Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Duramed Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Duramed Investigational Site
      • Clarksville, Tennessee, United States, 37043
        • Duramed Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Duramed Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Duramed Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Duramed Investigational Site
      • Houston, Texas, United States, 77074
        • Duramed Investigational Site
      • Houston, Texas, United States, 77030
        • Duramed Investigational Site
      • Houston, Texas, United States, 77015
        • Duramed Investigational Site
      • San Antonio, Texas, United States, 78229
        • Duramed Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Duramed Investigational Site
    • Washington
      • Spokane, Washington, United States, 92207
        • Duramed Investigational Site
      • Tacoma, Washington, United States, 98405
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Cenestin 0.3 mg Tablets
1 tablet daily
Other Names:
  • Synthetic conjugated estrogens, A
Placebo Comparator: 2
Other: Placebo
1 tablet daily
Other Names:
  • Placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in average frequency of moderate to severe hot flashes
Time Frame: Baseline to Day 28 and to Day 84
Baseline to Day 28 and to Day 84
Mean change in severity of moderate to severe hot flashes
Time Frame: Baseline to Day 28 and to Day 84
Baseline to Day 28 and to Day 84

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of Cenestin 0.3mg
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duramed Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

January 4, 2006

First Submitted That Met QC Criteria

January 4, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

July 3, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-CEN-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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