Conditions: Hypogonadism
Keywords: testosterone male hypogonadism low testosterone
Allocation: NON_RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: no

Brief summary:
Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.

Detailed description:
Five period cross-over study in which subjects received a single day of dosing in each period. Dosing was either QD or BID with one of two T esters (T-enanthate (TE) or T-undecanoate (TU)). Dosing was within 5 minutes of meals (breakfast and for BID dosing dinner). There was a minimum of a 5-day washout between periods. Subjects were hypogonadal men.

Arms:
arm 1: Period 2 - 200 mg T (as TU) QD Period 3 - 200 mg T (as TU) BID (100 mg/dose) Period 4 - 400 mg T (as TU) BID (200 mg/dose) arm 2: Period 1 - 400 mg T (as TE) QD Period 5 - 800 mg T (as TE) BID (400 mg/dose)

Interventions: intervention 1: Testosterone undecanoate intervention 2: Testosterone enanthate
Intervention descriptions: intervention 1: Single-day dose as QD or BID for 3 of 5 crossover periods intervention 2: Single-day dose for 2 of 5 crossover periods

Protocol document: