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Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Duramed Research
ClinicalTrials.gov Identifier:
NCT00592839
First received: December 20, 2007
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
Results First Received: February 4, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Nocturnal Vasomotor Symptoms
Interventions: Drug: SCE-B
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
0.3 mg SCE-B Daily SCE-B tablet 0.3 mg/day orally
0.625 mg SCE-B Daily SCE-B tablet 0.625 mg/day orally
Placebo Daily Placebo tablet daily orally

Participant Flow:   Overall Study
    0.3 mg SCE-B Daily     0.625 mg SCE-B Daily     Placebo Daily  
STARTED     53     52     52  
COMPLETED     51     48     46  
NOT COMPLETED     2     4     6  
Withdrawal by Subject                 1                 1                 3  
Protocol Violation                 1                 1                 2  
Adverse Event                 0                 1                 0  
Lost to Follow-up                 0                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
0.3 mg SCE-B Daily SCE-B tablet 0.3 mg/day orally
0.625 mg SCE-B Daily SCE-B tablet 0.625 mg/day orally
Placebo Daily Placebo tablet daily orally
Total Total of all reporting groups

Baseline Measures
    0.3 mg SCE-B Daily     0.625 mg SCE-B Daily     Placebo Daily     Total  
Number of Participants  
[units: participants]
 		  53     52     52     157  
Age, Customized  
[units: participants]
 		       
Between 30 and 65 years     53     52     52     157  
Age  
[units: years]
Mean ± Standard Deviation 		  53.9  ± 6.00     54.6  ± 5.38     53.8  ± 6.27     54.1  ± 5.87  
Gender  
[units: participants]
 		       
Female     53     52     52     157  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
United States     53     52     52     157  



  Outcome Measures
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1.  Primary:   Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes   [ Time Frame: Baseline to End of Treatment (Week 12) ]
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2.  Secondary:   Mean Change in Individual Sleep Parameters on a Three-point Scale   [ Time Frame: Baseline to End of Treatment (Week 12) ]
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3.  Secondary:   Mean Change in Stanford Sleepiness Scale   [ Time Frame: Baseline to End of Treatment (Week 12) ]
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4.  Secondary:   Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).   [ Time Frame: From baseline to End of Treatment (Week 12) ]
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5.  Secondary:   Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)   [ Time Frame: Baseline to End of Treatment (Week 12) ]
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6.  Secondary:   Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).   [ Time Frame: Baseline to End of Treatment (12 weeks) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Duramed Research Protocol Chair
Organization: Duramed Research
phone: 215-293-7279
e-mail: medicalaffairs@barrlabs.com


No publications provided by Duramed Research

Publications automatically indexed to this study:


Responsible Party: Duramed Research, Inc., Duramed Research, Inc
ClinicalTrials.gov Identifier: NCT00592839     History of Changes
Other Study ID Numbers: DR-ENJ-401
Study First Received: December 20, 2007
Results First Received: February 4, 2010
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration