Trial Outcomes & Findings for Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men (NCT NCT02697188)

Last Updated: 2018-11-01

Results Overview

The objective of the study was to determine the single day serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU formulation) administered once- and twice-daily to hypogonadal men.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Concentrations at -0.5, 0, 1, 2, 4, 8, 12, 13, 14, 16, 20, 24 and 34 hours post dose

Results posted on

2018-11-01

Participant Flow

Cross over study with 5 periods. Twelve subjects enrolled and completed 5 crossover periods each.

Participant milestones

Participant milestones
Measure	Testosterone Enanthate and Testosterone Undecanoate Testosterone Enanthate Periods 1 and 5 Single-day dose as QD Period 1 and BID Period 5 Testosterone Undecanoate: Single-day dose as QD Period 2 and BID Periods 3 and 4
TE Period 1 - 400 mg QD STARTED	12
TE Period 1 - 400 mg QD COMPLETED	12
TE Period 1 - 400 mg QD NOT COMPLETED	0
TU Period 2 - 200 mg QD STARTED	12
TU Period 2 - 200 mg QD COMPLETED	12
TU Period 2 - 200 mg QD NOT COMPLETED	0
TU Period 3 - 200 mg BID STARTED	12
TU Period 3 - 200 mg BID COMPLETED	12
TU Period 3 - 200 mg BID NOT COMPLETED	0
TU Period 4 - 400 BID STARTED	12
TU Period 4 - 400 BID COMPLETED	12
TU Period 4 - 400 BID NOT COMPLETED	0
TE Period 5 - 800 mg BID STARTED	12
TE Period 5 - 800 mg BID COMPLETED	12
TE Period 5 - 800 mg BID NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone Enanthate and Testosterone Undecanoate n=12 Participants Period 1 - 400 mg T (as TE) QD Period 5 - 800 mg T (as TE) BID (400 mg/dose) Testosterone enanthate: Single-day dose for 2 of 5 crossover periods 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) Testosterone undecanoate: Single-day dose as QD or BID for 3 of 5 crossover periods
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age, Continuous	53 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Region of Enrollment United States	12 participants n=99 Participants

PRIMARY outcome

Timeframe: Concentrations at -0.5, 0, 1, 2, 4, 8, 12, 13, 14, 16, 20, 24 and 34 hours post dose

Outcome measures

Outcome measures
Measure	Testosterone Enanthate and Testosterone Undecanoate n=12 Participants Period 1 - 400 mg T (as TE) QD Period 5 - 800 mg T (as TE) BID (400 mg/dose) Testosterone enanthate: Single-day dose for 2 of 5 crossover periods 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) Testosterone undecanoate: Single-day dose as QD or BID for 3 of 5 crossover periods
Mean Serum Testosterone Cavg TE Period 1 400 mg QD	293 ng/dL Standard Deviation 148
Mean Serum Testosterone Cavg TU Period 2 200 mg QD	246 ng/dL Standard Deviation 77
Mean Serum Testosterone Cavg TU Period 3 100 mg BID	281 ng/dL Standard Deviation 89
Mean Serum Testosterone Cavg TU Period 4 200 mg BID	385 ng/dL Standard Deviation 132
Mean Serum Testosterone Cavg TE Period 5 400 mg BID	316 ng/dL Standard Deviation 167

SECONDARY outcome

Timeframe: 24 hours post-dose in each period