Back to resultsPharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
Primary Purpose
Hypogonadism
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
testosterone matrix transdermal system
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring hypogonadism, testosterone, transdermal system
Eligibility Criteria
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
Sites / Locations
- Watson Investigational Site
- Watson Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TMTS treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Percent of Subjects With Testosterone Levels in the Normal Range.
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 Outcome Measures
Full Information
NCT ID
NCT01323140
First Posted
March 21, 2011
Last Updated
November 30, 2012
Sponsor
Watson Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01323140
Brief Title
Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
hypogonadism, testosterone, transdermal system
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMTS treatment
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
testosterone matrix transdermal system
Primary Outcome Measure Information:
Title
Percent of Subjects With Testosterone Levels in the Normal Range.
Description
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.
Time Frame
Day 29/30
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keshava Kumar, PhD, MHSA
Organizational Affiliation
Watson Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Watson Investigational Site
City
Ft. Meyers
State/Province
Florida
Country
United States
Facility Name
Watson Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
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