ORAL T-8 Oral Testosterone for Male Hormonal Contraception (Oral T8)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
John Amory, University of Washington
ClinicalTrials.gov Identifier:
NCT01167829
First received: July 20, 2010
Last updated: August 23, 2013
Last verified: August 2013
Results First Received: September 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Healthy
Interventions: Drug: Oral Testosterone
Drug: Acyline

  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
Subjects were recruited through news media (website)and college campus bulletin boards in Seattle, WA. between July-September 2010. All visits were at the University of Washington, Seattle, WA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
14 subjects were screened and 2 did not meet inclusion criteria for untreated high blood pressure and peripheral arterial disease.

Reporting Groups
  Description
Acyline and 0ral Testosterone Acyline 300 mcg/kg subcutaneous + 300mg modified slow-release oral testosterone tid

Participant Flow:   Overall Study
    Acyline and 0ral Testosterone  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  



  Baseline Characteristics
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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
Acyline and Oral Testosterone 300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg

Baseline Measures
    Acyline and Oral Testosterone  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Median ( Inter-Quartile Range )
  28.1  
  ( 19 to 51 )  
Gender  
[units: participants]
 
Female     0  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     12  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  24.2  ± 1.5  
Body Weight  
[units: kg]
Mean ± Standard Deviation
  79.9  ± 7.5  
Follicle-stimulating hormone (FSH)  
[units: IU/L]
Mean ± Standard Deviation
  3.2  ± 1.5  
Luteinizing hormone (LH)  
[units: IU/L]
Mean ± Standard Deviation
  5.4  ± 4.4  
Testosterone  
[units: ng/dL]
Mean ± Standard Deviation
  510  ± 13  
Prostate-specific antigen (PSA)  
[units: ng/mL]
Mean ± Standard Deviation
  0.91  ± 0.56  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Testosterone Concentration   [ Time Frame: baseline & day 9 ]

2.  Primary:   Mean Testosterone Concentration   [ Time Frame: baseline & day 9 ]

3.  Secondary:   Maximum Dihydrotestosterone (DHT) Concentration   [ Time Frame: baseline & day 9 ]

4.  Secondary:   Mean Dihydrotestosterone (DHT) Concentration   [ Time Frame: baseline & day 9 ]

5.  Secondary:   Maximum Sex Hormone-Binding Globulin (SHGB)Concentration   [ Time Frame: baseline & day 9 ]

6.  Secondary:   Mean SHGB Concentration   [ Time Frame: baseline & day 9 ]

7.  Secondary:   Maximum Estradiol Concentration   [ Time Frame: baseline & day 9 ]

8.  Secondary:   Mean Estradiol Concentration   [ Time Frame: baseline & day 9 ]

9.  Secondary:   Free T Maximum Concentration   [ Time Frame: baseline & day 9 ]

10.  Secondary:   Free Testosterone Mean Concentration   [ Time Frame: baseline & day 9 ]


  Serious Adverse Events


  Other Adverse Events


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


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
No text entered.  


Results Point of Contact:  
Name/Title: John Amory, MD
Organization: University of Washington, Dept. of Medicine
phone: (206) 616-1727
e-mail: jamory@u.washington.edu


Publications:
1. Plymate SR "Male Hypogonadism" in Principles and Practice of Endocrinology and Metabolism (3rd. Ed). Ed. Kenneth Becker, pp:1125-1150


Responsible Party: John Amory, University of Washington
ClinicalTrials.gov Identifier: NCT01167829     History of Changes
Other Study ID Numbers: 38636-D
Study First Received: July 20, 2010
Results First Received: September 25, 2012
Last Updated: August 23, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board