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

NCT ID: NCT00272935

Last Updated: 2012-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Hot Flashes

Keywords

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menopause vasomotor symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Cenestin 0.3 mg Tablets

Intervention Type DRUG

1 tablet daily

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 tablet daily

Interventions

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Cenestin 0.3 mg Tablets

1 tablet daily

Intervention Type DRUG

Placebo

1 tablet daily

Intervention Type OTHER

Other Intervention Names

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Synthetic conjugated estrogens, A Placebo tablets

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duramed Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Duramed Research, Inc.

Principal Investigators

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Duramed Research Protocol Chair

Role: STUDY_CHAIR

Duramed Research, Inc

Locations

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Duramed Investigational Site

Huntsville, Alabama, United States

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Montgomery, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Carmichael, California, United States

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Irvine, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Ramon, California, United States

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Brooksville, Florida, United States

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Coral Gables, Florida, United States

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Gainesville, Florida, United States

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Leesburg, Florida, United States

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Miami, Florida, United States

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Palm Springs, Florida, United States

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Venice, Florida, United States

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Alpharetta, Georgia, United States

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Douglasville, Georgia, United States

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Boise, Idaho, United States

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Evansville, Indiana, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Mayfield Heights, Ohio, United States

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Medford, Oregon, United States

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King of Prussia, Pennsylvania, United States

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North Wales, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Bristol, Tennessee, United States

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Clarksville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Countries

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United States

Other Identifiers

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BR-CEN-301

Identifier Type: -

Identifier Source: org_study_id