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Effects of Testosterone in Women With Depression

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ClinicalTrials.gov Identifier: NCT00676676
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : November 30, 2012
Last Update Posted : November 30, 2012
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Depression
Intervention: Drug: Testosterone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Testosterone Testosterone Patch 300mcg replaced every 3-4 days

Participant Flow:   Overall Study
    Testosterone
STARTED   9 
COMPLETED   9 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Testosterone Testosterone Patch 300mcg replaced every 3-4 days

Baseline Measures
   Testosterone 
Overall Participants Analyzed 
[Units: Participants]
 		 9 
Age 
[Units: Participants]
 		 
<=18 years   0 
Between 18 and 65 years   9 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 48.1  (12.2) 
Gender 
[Units: Participants]
 		 
Female   9 
Male   0 
Region of Enrollment 
[Units: Participants]
 		 
United States   9 


  Outcome Measures

1.  Primary:   Montgomery-Asberg Depression Rating Scale (MADRS) Scale   [ Time Frame: Baseline, 2-week, 8-week ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  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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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Karen K. Miller
Organization: Massachusetts General Hospita
phone: 617-726-3870
e-mail: kkmiller@partners.org



Responsible Party: Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00676676     History of Changes
Other Study ID Numbers: 2007p000348
First Submitted: May 8, 2008
First Posted: May 13, 2008
Results First Submitted: May 10, 2012
Results First Posted: November 30, 2012
Last Update Posted: November 30, 2012