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Trial record 45 of 236 for:    PRASTERONE

Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF) (DHEAFert2)

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: NCT00948857
Recruitment Status : Terminated (Lack of recruitment.)
First Posted : July 29, 2009
Results First Posted : September 5, 2012
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):
David H. Barad, Center for Human Reproduction

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Premature Ovarian Failure
Interventions Dietary Supplement: Dehydroepiandrosterone
Dietary Supplement: Placebo
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dehydroepiandrosterone 25 mg Tid po Blinded Placebo
Hide Arm/Group Description Dehydroepiandrosterone 25 mg tid po Blinded placebo
Period Title: Overall Study
Started 3 2
Completed 2 [1] 2
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
[1]
3 completed and 1 dropped out.
Arm/Group Title Dehydroepiandrosterone 25 mg Tid po Blinded Placebo Total
Hide Arm/Group Description Dehydroepiandrosterone 25 mg tid po Blinded placebo Total of all reporting groups
Overall Number of Baseline Participants 3 2 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
2
 100.0%
5
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 2 participants 5 participants
38  (3) 38  (3) 38  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Female
3
 100.0%
2
 100.0%
5
 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 3 participants 2 participants 5 participants
3 2 5
1.Primary Outcome
Title Live Birth
Hide Description [Not Specified]
Time Frame 24 months
Outcome Measure Data Not Reported
2.Primary Outcome
Title Live Birth
Hide Description Live Birth outcome compared between DHEA active treatment and Placebo
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was closed for futility because of difficulty finding patients willing to undergo randomization.
Arm/Group Title DHEA Placebo
Hide Arm/Group Description:
Dehydroepiandrosterone 25 mg tid po
Blinded placebo
Overall Number of Participants Analyzed 3 2
Measure Type: Number
Unit of Measure: participants
0 0
3.Secondary Outcome
Title Endocrine Effects
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Androgen Side Effects
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Clinical Pregnancy
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dehydroepiandrosterone 25 mg Tid po Blinded Placebo
Hide Arm/Group Description Dehydroepiandrosterone 25 mg tid po Blinded placebo
All-Cause Mortality
Dehydroepiandrosterone 25 mg Tid po Blinded Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dehydroepiandrosterone 25 mg Tid po Blinded Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dehydroepiandrosterone 25 mg Tid po Blinded Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Termination due to lack of consenting participants.
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. Norbert Gleicher
Organization: Center for Human Reproduction
Phone: 212-994-4400
EMail: ngleicher@thechr.com
Layout table for additonal information
Responsible Party: David H. Barad, Center for Human Reproduction
ClinicalTrials.gov Identifier: NCT00948857     History of Changes
Other Study ID Numbers: 092508-01
First Submitted: July 28, 2009
First Posted: July 29, 2009
Results First Submitted: August 2, 2012
Results First Posted: September 5, 2012
Last Update Posted: September 10, 2012