Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone

NCT00161421 | Completed Phase 2

• 4 other identifiers: 04-4115-DHD42454K23HD045386GSK002590
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.

Conditions

Contraception; Hypogonadism

Keywords

Male Contraception; Testosterone; Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Elevations in serum testosterone

  2 months

Secondary Outcomes (1)

• Monitoring for any adverse changes in liver function or general health.

  2 months

Study Arms (1)

1

EXPERIMENTAL

Lupron injection at Day -14 with load of dutasteride (24.5 mg) followed by 13 days of Dutasteride. On day 0, 11, 0.5 mg Dutasteride taken daily for next 11 days. Day 1 Oral Testosterone (T) 200mg without food, Day 2 Oral T 400 mg without food, Day 3 Oral T 400 mg with food. During the 2nd week of the study, we will repeat the testosterone doses, with a 2nd formulation of testosterone (Day8, 9, \& 10.

Drug: Oral Testosterone; Drug: Leuprolide (Lupron); Drug: Dutasteride

Interventions

Oral Testosterone DRUG

200 mg (Formulation A) Day 1 400 mg (Formulation A) Day 2, fasting; Day 3, with food 200 mg (Formulation B) Day 8, fasting 400 mg (Formulation B) Day 9, fasting; Day 10, with food

1

Leuprolide (Lupron) DRUG

7.5 mg injection into muscle (once) (Day -14)

1

Dutasteride DRUG

24.5 mg load (3.5 mg x 7 capsulesDay -14 only) 0.5 mg daily (Day -13 to day -1)

Also known as: Avodart

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male 18-50 yrs old
• In good general health based on normal screening evaluation (consisting of medical history, physical exam, normal serum chemistry, hematology, and baseline hormone levels)

You may not qualify if:

• Poor general health, with abnormal blood results at screening
• A known history of alcohol or drug abuse
• Participation in a long-term male contraceptive study within three months of screening

Sponsors & Collaborators

• University of Washington: lead
• GlaxoSmithKline: collaborator
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Page ST, Bremner WJ, Clark RV, Bush MA, Zhi H, Caricofe RB, Smith PM, Amory JK. Nanomilled oral testosterone plus dutasteride effectively normalizes serum testosterone in normal men with induced hypogonadism. J Androl. 2008 Mar-Apr;29(2):222-7. doi: 10.2164/jandrol.107.002956. Epub 2007 Dec 12.

  PMID: 18077826 RESULT

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone; Leuprolide; Dutasteride

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Azasteroids; Steroids, Heterocyclic

Study Officials

• William J Bremner, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: March 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: September 19, 2008

Record last verified: 2008-09

Locations

US (1)