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

PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

July 31, 2006

Study Completion Date

July 31, 2006

Conditions
ContraceptionHypogonadism
Interventions
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)

DRUG

Dutasteride

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

Trial Locations (1)

98195

University of Washington, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

National Institutes of Health (NIH)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Washington

OTHER