Trial Outcomes & Findings for Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men (NCT NCT01104246)

Results Overview

A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

Day 28/29

Results posted on

2012-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Testosterone Transdermal Systems Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
Overall Study STARTED	40
Overall Study Baseline Characteristics Measured	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Testosterone Transdermal Systems Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
Overall Study Withdrawal by Subject	1
Overall Study did not meet inclusion criteria	4

Baseline Characteristics

Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone Transdermal Systems n=35 Participants Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age Continuous	55.1 years STANDARD_DEVIATION 8.70 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28/29

Population: Per-protocol Population was used for the analysis. PP population included subjects who completed the treatment period of the study, who did not have more than two consecutive missing data, and who did not have any major protocol deviations.

A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.

Outcome measures

Outcome measures
Measure	Testosterone Transdermal Systems n=35 Participants Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours	463 ng/dL Standard Deviation 122.1

Adverse Events

Testosterone Transdermal Systems

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Testosterone Transdermal Systems n=40 participants at risk Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
Skin and subcutaneous tissue disorders Application site pruritus	15.0% 6/40 • Number of events 7 • 28 days
Skin and subcutaneous tissue disorders Application site vesicles	5.0% 2/40 • Number of events 2 • 28 days
Musculoskeletal and connective tissue disorders Back Pain	5.0% 2/40 • Number of events 2 • 28 days

Additional Information

Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research

Watson Laboratories, Inc.

Phone: 801-588-6641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60