Oral Androgens in Man-4: (Short Title: Oral T-4)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00399165
First received: November 9, 2006
Last updated: September 18, 2008
Last verified: September 2008

November 9, 2006
September 18, 2008
November 2006
May 2007   (final data collection date for primary outcome measure)
Dutasteride can suppress the secretion of LH and FSH after four weeks of administration. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
1)that Oral testosterone enanthate (TE) plus dutasteride can suppress the secretion of LH and FSH after four weeks of administration.
Complete list of historical versions of study NCT00399165 on ClinicalTrials.gov Archive Site
The ability of oral testosterone enanthate plus dutasteride to maintain short-term androgen-medicated endpoints such as mood and sexual function over the 4-week treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The ability of oral testosterone enanthate plus dutasteride to maintain shor-term androgen-medicated endpoints such as mood and sexual function over the 4-week treatment period
Not Provided
Not Provided
 
Oral Androgens in Man-4: (Short Title: Oral T-4)
Oral Androgens in Man-4: Gonadotropin Suppression Medicated by Oral Testosterone Enanthate in Oil Plus Dutasteride (Short Title: Oral T-4)

The protocol was designed to address the hypothesis that oral testosterone enanthate plus dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In addition, we will compare the gonadotropin suppression mediated by a dose of testosterone enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in the normal range throughout the day, with the same dose (800 mg once daily) administered once daily. This larger once-daily dose is expected to result in a higher peak and lower trough by the end of the dosing interval

This study will be carried out in a double-blinded fashion, so neither the subject nor the investigator will be aware of treatment assignment during the study. This protocol is designed to address the hypothesis that oral testosterone enanthate plus dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In addition, we will compare the gonadotropin suppression mediated by a dose of testosterone enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in the normal range throughout the day, with the same dose (800 mg once daily) administered once daily. This larger once-daily dose is expected to result in a higher peak and lower trough by the end of the dosing interval. Secondary endpoints in this study include the ability of oral testosterone enanthate plus dutasteride to maintain short-term androgen-mediated endpoints such as mood and sexual function over the 4-week treatment period as well as weekly measures of safety, including blood counts, PSA and liver and kidney function.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Contraception
  • Drug: Testosterone Enanthate
    Oral Testosterone 400 mg orally for 28 days
    Other Name: Delatestryl
  • Drug: Testosterone Enanthate
    Oral Testosterone 800 mg orally for 28 days
    Other Name: Delatestryl
  • Drug: Dutasteride
    dutasteride 0.5 mg orally, once daily for 28 days
    Other Name: Avodart
  • Other: placebo sesame oil
    placebo sesame oil
  • Drug: Dutasteride
    24.5 mg po once (Day 0)
    Other Name: Avodart
  • Active Comparator: 1
    Oral Testosterone enanthate in sesame oil, 400 mg po (orally), BID (twice daily) + dutasteride 0.5 mg orally, qd (once daily) for 28 days + dutasteride load 24.5 mg po once
    Interventions:
    • Drug: Testosterone Enanthate
    • Drug: Dutasteride
    • Drug: Dutasteride
  • Active Comparator: 2
    Oral Testosterone sesame oil, 800 mg po (orally), qd (in am daily) + placebo sesame oil (in pm daily) + dutasteride 0.5 mg orally, qd (once daily) for 28 days + dutasteride load 24.5 mg po once
    Interventions:
    • Drug: Testosterone Enanthate
    • Drug: Dutasteride
    • Other: placebo sesame oil
    • Drug: Dutasteride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2007
May 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males between 18 to 55 years of age
  • In good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal serum chemistry, hematology, and baseline hormone levels)
  • Subject must agree not to participate in another research drug study for the duration of the study
  • Subject must agree to not donate blood during the study
  • Subject must be willing to comply with the study protocol and procedures

Exclusion Criteria:

  • Men in poor general health, with abnormal blood results (clinical laboratory tests or hormone values)
  • A known history of alcohol or drug abuse
  • A history of testicular disease or severe testicular trauma,
  • A history of bleeding disorders or current use of anti-coagulants
  • A history of sleep apnea and/or major psychiatric disorders
  • A body-mass index greater than 35,
  • A history of or current use of testosterone
  • Infertility
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00399165
06-2962-A, U54 HD42454, K23 HD045386
No
John K Amory, MD, MPH, University of Washington
University of Washington
GlaxoSmithKline
Principal Investigator: John K Amory, MD, MPH University of Washington
University of Washington
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP