Conditions: Hypogonadism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: no

Brief summary:
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

Detailed description:

Arms:
arm 1: TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day) arm 2: TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day) arm 3: TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)

Interventions: intervention 1: 10.0 mg of Testosterone, 4.0% TID intervention 2: 13.5 mg of Testosterone, 4.5% B.I.D intervention 3: 11.25 mg of Testosterone, 4.5% T.I.D
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: