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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
History of Changes
  Purpose

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


Condition Intervention Phase
Contraception
 Drug: Testosterone Enanthate
Drug: Dutasteride
Other: placebo sesame oil
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Oral Androgens in Man-4: Gonadotropin Suppression Medicated by Oral Testosterone Enanthate in Oil Plus Dutasteride (Short Title: Oral T-4)

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Dutasteride can suppress the secretion of LH and FSH after four weeks of administration. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: November 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: Testosterone Enanthate
Oral Testosterone 400 mg orally for 28 days
Other Name: Delatestryl
Drug: Dutasteride
dutasteride 0.5 mg orally, once daily for 28 days
Other Name: Avodart
Drug: Dutasteride
24.5 mg po once (Day 0)
Other Name: Avodart
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
 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399165

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
GlaxoSmithKline
Investigators
Principal Investigator: John K Amory, MD, MPH University of Washington
  More Information

Additional Information:
University of Washington  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: John K Amory, MD, MPH, University of Washington
ClinicalTrials.gov Identifier: NCT00399165     History of Changes
Other Study ID Numbers: 06-2962-A, U54 HD42454, K23 HD045386
Study First Received: November 9, 2006
Last Updated: September 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Oral Contraception for Men
Contraceptive agent

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Androgens
Methyltestosterone
Contraceptive Agents
Dutasteride
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Reproductive Control Agents
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013