Trial Outcomes & Findings for Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems (NCT NCT01323140)

Results Overview

Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (\>= 300 ng/dL to \<= 1030 ng/dL), at least 85% of subjects with Cmax \<= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax \>= 2500 ng/dL.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Day 29/30

Results posted on

2013-01-01

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment
Overall Study STARTED	40
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=40 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	49.1 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 29/30

Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (\>= 300 ng/dL to \<= 1030 ng/dL), at least 85% of subjects with Cmax \<= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax \>= 2500 ng/dL.

Outcome measures

Outcome measures
Measure	Treatment n=38 Participants As specified in the Protocol, subjects were dose-titrated during treatment and subjects at all resulting dose levels were pooled for primary efficacy analysis. After dose-titration, 20 subjects were receiving TMTS at dose level B (one 48 cm2 TMTS) and 18 subjects were receiving TMTS at dose level C (one 48 cm2 and one 28 cm2 TMTS). See also Arm description.
Percent of Subjects With Testosterone Levels in the Normal Range.	68.4 percentage of participants 95% Confidence Interval 132.9 • Interval 53.6 to 83.2

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=40 participants at risk
General disorders Application site irritation	7.5% 3/40 • Number of events 4 • First test article administration to study exit.
Nervous system disorders Headache	7.5% 3/40 • Number of events 3 • First test article administration to study exit.

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