A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes
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
1 other identifier
interventional
400
1 country
49
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2005
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 4, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJuly 3, 2012
July 1, 2009
1.4 years
January 4, 2006
June 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean change in average frequency of moderate to severe hot flashes
Baseline to Day 28 and to Day 84
Mean change in severity of moderate to severe hot flashes
Baseline to Day 28 and to Day 84
Secondary Outcomes (1)
Safety and tolerability of Cenestin 0.3mg
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any contraindication to natural or synthetic estrogens
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duramed Researchlead
Study Sites (49)
Duramed Investigational Site
Huntsville, Alabama, 35801, United States
Duramed Investigational Site
Montgomery, Alabama, 36116, United States
Duramed Investigational Site
Phoenix, Arizona, 85013, United States
Duramed Investigational Site
Phoenix, Arizona, 85032, United States
Duramed Investigational Site
Tucson, Arizona, 85712, United States
Duramed Investigational Site
Carmichael, California, 95608, United States
Duramed Investigational Site
Irvine, California, 92618, United States
Duramed Investigational Site
San Diego, California, 72108, United States
Duramed Investigational Site
San Diego, California, 92103, United States
Duramed Investigational Site
San Diego, California, 92123, United States
Duramed Investigational Site
San Ramon, California, 94583, United States
Duramed Investigational Site
Brooksville, Florida, 34613, United States
Duramed Investigational Site
Coral Gables, Florida, 33134, United States
Duramed Investigational Site
Gainesville, Florida, 32607, United States
Duramed Investigational Site
Leesburg, Florida, 34748, United States
Duramed Investigational Site
Miami, Florida, 33143, United States
Duramed Investigational Site
Palm Springs, Florida, 33461, United States
Duramed Investigational Site
Venice, Florida, 34285, United States
Duramed Investigational Site
Alpharetta, Georgia, 30005, United States
Duramed Investigational Site
Douglasville, Georgia, 30134, United States
Duramed Investigational Site
Boise, Idaho, 83712, United States
Duramed Investigational Site
Evansville, Indiana, 47714, United States
Duramed Investigational Site
Lexington, Kentucky, 40509, United States
Duramed Investigational Site
Baltimore, Maryland, 21224, United States
Duramed Investigational Site
Lincoln, Nebraska, 68510, United States
Duramed Investigational Site
Las Vegas, Nevada, 89146, United States
Duramed Investigational Site
Albuquerque, New Mexico, 87102, United States
Duramed Investigational Site
Cleveland, Ohio, 44122, United States
Duramed Investigational Site
Columbus, Ohio, 43213, United States
Duramed Investigational Site
Mayfield Heights, Ohio, 44124, United States
Duramed Investigational Site
Medford, Oregon, 97504, United States
Duramed Investigational Site
King of Prussia, Pennsylvania, 19406, United States
Duramed Investigational Site
North Wales, Pennsylvania, 19454, United States
Duramed Investigational Site
Philadelphia, Pennsylvania, 19107, United States
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114, United States
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
Duramed Investigational Site
Charleston, South Carolina, 29401, United States
Duramed Investigational Site
Bristol, Tennessee, 37620, United States
Duramed Investigational Site
Clarksville, Tennessee, 37043, United States
Duramed Investigational Site
Nashville, Tennessee, 37203, United States
Duramed Investigational Site
Dallas, Texas, 75390, United States
Duramed Investigational Site
Fort Worth, Texas, 76104, United States
Duramed Investigational Site
Houston, Texas, 77015, United States
Duramed Investigational Site
Houston, Texas, 77030, United States
Duramed Investigational Site
Houston, Texas, 77074, United States
Duramed Investigational Site
San Antonio, Texas, 78229, United States
Duramed Investigational Site
Norfolk, Virginia, 23507, United States
Duramed Investigational Site
Spokane, Washington, 92207, United States
Duramed Investigational Site
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Duramed Research Protocol Chair
Duramed Research, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 4, 2006
First Posted
January 9, 2006
Study Start
December 1, 2005
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
July 3, 2012
Record last verified: 2009-07