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Trial record 84 of 7500 for:    Area Under Curve

ORAL T-6: Oral Androgens in Man-6 (ORAL-T-6)

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ClinicalTrials.gov Identifier: NCT00663793
Recruitment Status : Completed
First Posted : April 22, 2008
Results First Posted : January 24, 2011
Last Update Posted : January 24, 2011
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
University of Washington

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Contraception
Hypogonadism
Interventions Drug: Acyline
Drug: Testosterone
Drug: Finasteride
Enrollment 16
Recruitment Details Subjects were recruited through news media (newspaper, website) and college campus bulletin boards in Seattle WA, between April 2008-March 2009.
Pre-assignment Details 19 participants recruited; 19 screened, 2 excluded.
Arm/Group Title Testosterone Only Testosterone Plus Finasteride
Hide Arm/Group Description (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. (Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
Period Title: Overall Study
Started 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title Testosterone Only Testosterone Plus Finasteride Total
Hide Arm/Group Description (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. (Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
16
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
8
 100.0%
16
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 16
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 8 participants 8 participants 16 participants
26  (4) 28  (8) 27  (4)
Estradiol  
Mean (Standard Deviation)
Unit of measure:  pmol/L
Number Analyzed 8 participants 8 participants 16 participants
70.1  (16.1) 114  (54) 92.0  (35.0)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 8 participants 8 participants 16 participants
178  (5) 179  (7) 178.5  (6)
Sex Hormone Binding Globulin (SHBG)  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 8 participants 8 participants 16 participants
35.5  (12.8) 32.5  (19.6) 34  (16.2)
Testosterone (T)  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 8 participants 8 participants 16 participants
14.5  (2.5) 16.8  (8.9) 15.65  (5.7)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 8 participants 8 participants 16 participants
83  (18) 89  (22) 86  (20)
1.Primary Outcome
Title Area Under the Curve-Serum T
Hide Description [Not Specified]
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Testosterone Only Testosterone Plus Finasteride
Hide Arm/Group Description:
(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
Overall Number of Participants Analyzed 8 8
Mean (Standard Error)
Unit of Measure: nmol*h/L
external matrix 'immediate' release 143  (47) 198  (86)
external matrix 'fast' release 144  (44) 384  (273)
external matrix 'slow' release 162  (60) 237  (141)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone Only, Testosterone Plus Finasteride
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample size of 8 per group was estimated to confer an 80% power to detect a 40% difference in testosterone AUC with a standard deviation of 20% at an alpha of 0.05
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon sign-rank
Comments [Not Specified]
2.Secondary Outcome
Title Area Under the Curve-serum DHT
Hide Description [Not Specified]
Time Frame 14-days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Testosterone Only Testosterone Plus Finasteride
Hide Arm/Group Description:
(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
Overall Number of Participants Analyzed 8 8
Mean (Standard Error)
Unit of Measure: nmol*h/L
external matrix 'immediate' release 36  (13) 23  (10)
external matrix 'fast' release 42  (21) 26  (12)
external matrix 'slow' release 39  (16) 26  (11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone Only, Testosterone Plus Finasteride
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments No power calculation was performed for this pilot study.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon sign-rank
Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Curve-E2
Hide Description [Not Specified]
Time Frame 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Testosterone Only Testosterone Plus Finasteride
Hide Arm/Group Description:
(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: nmol*h/L
external matrix 'immediate' release 1812  (405) 2241  (783)
external matrix 'fast' release 1961  (528) 2002  (861)
external matrix 'slow' release 1944  (652) 3129  (1574)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Testosterone Only, Testosterone Plus Finasteride
Comments Area-under-the-curve for serum estradiol
Type of Statistical Test Non-Inferiority or Equivalence
Comments No power calculation was performed for this pilot study
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Testosterone Only Testosterone Plus Finasteride
Hide Arm/Group Description (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. (Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.
All-Cause Mortality
Testosterone Only Testosterone Plus Finasteride
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Testosterone Only Testosterone Plus Finasteride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Testosterone Only Testosterone Plus Finasteride
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/8 (37.50%)      6/8 (75.00%)    
Endocrine disorders     
Elevated aspartate aminotransferase   1/8 (12.50%)  1 0/8 (0.00%)  0
Hot flashes   2/8 (25.00%)  3 4/8 (50.00%)  5
General disorders     
Fatigue   0/8 (0.00%)  0 4/8 (50.00%)  7
Headache   3/8 (37.50%)  4 3/8 (37.50%)  3
Reproductive system and breast disorders     
Decreased Libido   1/8 (12.50%)  2 2/8 (25.00%)  2
Indicates events were collected by systematic assessment
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: John K Amory, MD, MPH
Organization: University of Washington
Phone: 206-616-1727
EMail: jamory@u.washington.edu
Layout table for additonal information
Responsible Party: John K Amory, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT00663793     History of Changes
Other Study ID Numbers: 33738-B
U54HD42456-06 ( Other Grant/Funding Number: NIH/NICHD )
K23HD045386 ( U.S. NIH Grant/Contract )
First Submitted: April 18, 2008
First Posted: April 22, 2008
Results First Submitted: June 25, 2010
Results First Posted: January 24, 2011
Last Update Posted: January 24, 2011