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Trial record 52 of 235 for:    PRASTERONE

Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00310791
Recruitment Status : Completed
First Posted : April 5, 2006
Results First Posted : February 1, 2013
Last Update Posted : April 11, 2018
Sponsor:
Collaborators:
United States Department of Defense
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Catherine M. Gordon, Boston Children’s Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Anorexia Nervosa
Interventions Drug: Hormone replacement therapy (estrogen/progestin)
Other: Placebo (Sugar Pill)
Drug: Dehydroepiandrosterone (DHEA)
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Active
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 40 40
Completed 30 30
Not Completed 10 10
Arm/Group Title Placebo Active Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
<=18 years
3
   7.5%
1
   2.5%
4
   5.0%
Between 18 and 65 years
37
  92.5%
39
  97.5%
76
  95.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
21  (4) 24  (6) 22  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
40
 100.0%
40
 100.0%
80
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Areal Bone Density by DXA
Hide Description [Not Specified]
Time Frame 18-Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:
Sugar Pill
DHEA+HRT
Overall Number of Participants Analyzed 30 31
Mean (Standard Deviation)
Unit of Measure: g/cm2
0.88  (0.10) 0.89  (0.10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Active
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Placebo Active
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Active
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Active
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Catherine Gordon
Organization: Children's Hospital Boston
Phone: 401-444-4712
EMail: cgordon1@lifespan.org
Publications of Results:
Layout table for additonal information
Responsible Party: Catherine M. Gordon, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT00310791     History of Changes
Other Study ID Numbers: Anorexia04
R01HD043869 ( U.S. NIH Grant/Contract )
First Submitted: April 3, 2006
First Posted: April 5, 2006
Results First Submitted: June 22, 2011
Results First Posted: February 1, 2013
Last Update Posted: April 11, 2018