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A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

NCT ID: NCT00522431

Last Updated: 2017-10-05

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

PHASE3

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-03-31

Brief Summary

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Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.

Detailed Description

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Conditions

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Hypogonadism

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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1

2% testosterone gel

Group Type EXPERIMENTAL

Testosterone

Intervention Type DRUG

2% gel

Interventions

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Testosterone

2% gel

Intervention Type DRUG

Other Intervention Names

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Fortigel

Eligibility Criteria

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Inclusion Criteria

* Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:

* Single serum total testosterone concentration \< 250 ng/dL, or
* Two consecutive serum total testosterone concentrations \< 300 ng/dL (determined at least one week apart during the screening period).
* Has a BMI ≥ 22 kg/m2 and \< 35 kg/m2.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Endo Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liz Waldie

Role: STUDY_DIRECTOR

Strakan Pharmaceuticals, Inc.

Other Identifiers

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FOR01C

Identifier Type: -

Identifier Source: org_study_id