An Open Label, Dose-Proportionality, Bioavailability and Dose- Titration Investigation of the Pharmacokinetics, Metabolism, Efficacy and Safety of Two Testosterone Matrix Transdermal Systems (28 cm2 and 48 cm2) in Hypogonadal Men
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Percent of Subjects With Testosterone Levels in the Normal Range.
Study Overview
Brief Summary
Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.
Detailed Description
The present study is designed to characterize efficacy and safety of testosterone from the Watson's testosterone matrix transdermal system (TMTS).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male, 18 - 65 years of age;
- •Documented testosterone deficiency;
- •BMI 18 to 33.
Exclusion Criteria
- •Evidence of prostate cancer and benign prostate hyperplasia;
- •Taking medications that interfere testosterone metabolism;
- •History of alcohol or drug substance abuse;
- •Abnormal ECG;
- •Allergic to transdermal products;
- •Skin condition that interfere transdermal system application and assessment
Arms & Interventions
TMTS treatment
Following a lead-in dose-proportionality phase (Days 1-2) and a site-to-site bioavailability phase (Days 2-9), subjects were dosed for efficacy analysis beginning on Day 9 at dose level B (a single 48 cm2 testosterone matrix transdermal system). Based on pharmacokinetic (PK) analysis of blood samples drawn on Day 16, on Day 22 subjects could be dose-titrated up to dose level C (one 28 cm2 plus one 48 cm2 TMTS), down to dose level A (one 28 cm2 TMTS), or remain at dose level B. Subjects at all dose levels were pooled for primary efficacy analysis on Days 29/30.
Intervention: testosterone matrix transdermal system (Drug)
Outcomes
Primary Outcomes
Percent of Subjects With Testosterone Levels in the Normal Range.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported