Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone
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|ClinicalTrials.gov Identifier: NCT00161421|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 19, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Contraception Hypogonadism||Drug: Oral Testosterone Drug: Leuprolide (Lupron) Drug: Dutasteride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Androgens in Man-3: Pharmacokinetics of Oral Testosterone With Concomitant Inhibition of 5α-Reductase by Dutasteride Short Title: ORAL T-3|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
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
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
Drug: Leuprolide (Lupron)
7.5 mg injection into muscle (once) (Day -14)
24.5 mg load (3.5 mg x 7 capsulesDay -14 only) 0.5 mg daily (Day -13 to day -1)
Other Name: Avodart
- Elevations in serum testosterone [ Time Frame: 2 months ]
- Monitoring for any adverse changes in liver function or general health. [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161421
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||William J Bremner, MD, PhD||University of Washington|