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

NCT01323140 | Completed Phase 2 Results

• 1 other identifier: TM1103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hypogonadism

Keywords

hypogonadism, testosterone, transdermal system

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 29/30

Study Arms (1)

TMTS treatment

EXPERIMENTAL

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

Interventions

testosterone matrix transdermal system DRUG

TMTS treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, 18 - 65 years of age;
• Documented testosterone deficiency;
• BMI 18 to 33.

You may not qualify if:

• 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

Sponsors & Collaborators

• Watson Pharmaceuticals: lead

Study Sites (2)

Watson Investigational Site

Fort Meyers, Florida, United States

Location

Watson Investigational Site

Tacoma, Washington, United States

Location

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research
• Organization: Watson Laboratories, Inc.

gary.hoel@watson.com

801-588-6641

Study Officials

• Keshava Kumar, PhD, MHSA

  Watson Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 25, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 1, 2013
• Results First Posted: January 1, 2013

Record last verified: 2012-11

Locations

US (2)