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

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ClinicalTrials.gov Identifier: NCT00272935
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : July 3, 2012
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hot Flashes Drug: Cenestin 0.3 mg Tablets Other: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Cenestin 0.3 mg Tablets
1 tablet daily
Other Name: Synthetic conjugated estrogens, A
Placebo Comparator: 2 Other: Placebo
1 tablet daily
Other Name: Placebo tablets


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in average frequency of moderate to severe hot flashes [ Time Frame: Baseline to Day 28 and to Day 84 ]
  2. Mean change in severity of moderate to severe hot flashes [ Time Frame: Baseline to Day 28 and to Day 84 ]

Secondary Outcome Measures :
  1. Safety and tolerability of Cenestin 0.3mg [ Time Frame: Throughout study ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272935


  Show 49 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Research Protocol Chair Duramed Research, Inc
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00272935     History of Changes
Other Study ID Numbers: BR-CEN-301
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: July 2009

Keywords provided by Teva Pharmaceutical Industries:
menopause
vasomotor symptoms

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Estrogens
Estrogens, Conjugated (USP)
 Estrogens, conjugated synthetic A
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs