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Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men

NCT ID: NCT01104246

Last Updated: 2012-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-09-30

Brief Summary

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The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.

Detailed Description

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Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.

Conditions

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Hypogonadism

Keywords

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Hypogonadism Testosterone Hormone replacement therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Testosterone Transdermal Systems

Testosterone

Group Type EXPERIMENTAL

Testerone Transdermal System

Intervention Type DRUG

Transdermal testosterone applied daily for 4 weeks

Interventions

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Testerone Transdermal System

Transdermal testosterone applied daily for 4 weeks

Intervention Type DRUG

Other Intervention Names

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Testosterone

Eligibility Criteria

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Inclusion Criteria

* Males in good general health, 18 years of age or older.
* Have a previously documented testosterone deficiency.
* Willing and able to comply with the requirements of the protocol.

Exclusion Criteria

* Have a history of intolerance to Androderm or other testosterone products.
* Prostate specific antigen (PSA) level ≥ 4.0 ng/mL
* Prostate cancer or severe benign prostatic hypertrophy (BPH)
* Have significant abnormalities in the physical examination at screening.
* Have current dermatological disease, skin damage or blemishes.
* Have participated in an investigational drug study within 30 days prior to screening.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keshava Kumar, PhD, MHSA

Role: STUDY_DIRECTOR

Watson Laboratories

Locations

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Watson investigational site

Miramar, Florida, United States

Site Status

Watson investigational site

Omaha, Nebraska, United States

Site Status

Watson investigational site

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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AND1001

Identifier Type: -

Identifier Source: org_study_id