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Trial record 79 of 213 for:    "Hypogonadism" | "Androgens"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01323140
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : January 1, 2013
Last Update Posted : January 1, 2013
Information provided by (Responsible Party):
Watson Pharmaceuticals

Brief Summary:
Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: testosterone matrix transdermal system Phase 2

Detailed Description:
The present study is designed to characterize efficacy and safety of testosterone from the Watson's testosterone matrix transdermal system (TMTS).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Drug: testosterone matrix transdermal system

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01323140

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United States, Florida
Watson Investigational Site
Ft. Meyers, Florida, United States
United States, Washington
Watson Investigational Site
Tacoma, Washington, United States
Sponsors and Collaborators
Watson Pharmaceuticals
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Study Director: Keshava Kumar, PhD, MHSA Watson Pharmaceuticals

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Responsible Party: Watson Pharmaceuticals Identifier: NCT01323140     History of Changes
Other Study ID Numbers: TM1103
First Posted: March 25, 2011    Key Record Dates
Results First Posted: January 1, 2013
Last Update Posted: January 1, 2013
Last Verified: November 2012
Keywords provided by Watson Pharmaceuticals:
hypogonadism, testosterone, transdermal system
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents