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

September 18, 2008 updated by: University of Washington

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Delatestryl
Drug: Testosterone Enanthate
Oral Testosterone 800 mg orally for 28 days
Other Names:
  • Delatestryl
Drug: Dutasteride
dutasteride 0.5 mg orally, once daily for 28 days
Other Names:
  • Avodart
Drug: Dutasteride
24.5 mg po once (Day 0)
Other Names:
  • 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 400 mg orally for 28 days
Other Names:
  • Delatestryl
Drug: Testosterone Enanthate
Oral Testosterone 800 mg orally for 28 days
Other Names:
  • Delatestryl
Drug: Dutasteride
dutasteride 0.5 mg orally, once daily for 28 days
Other Names:
  • Avodart
Drug: Dutasteride
24.5 mg po once (Day 0)
Other Names:
  • Avodart
Other: placebo sesame oil
placebo sesame oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dutasteride can suppress the secretion of LH and FSH after four weeks of administration.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

November 9, 2006

First Submitted That Met QC Criteria

November 9, 2006

First Posted (Estimate)

November 14, 2006

Study Record Updates

Last Update Posted (Estimate)

September 22, 2008

Last Update Submitted That Met QC Criteria

September 18, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-2962-A
  • U54HD042454 (U.S. NIH Grant/Contract)
  • K23HD045386 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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