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A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

NCT ID: NCT01703741

Last Updated: 2017-10-06

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

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-10-31

Brief Summary

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This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.

Detailed Description

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Conditions

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Adult Male 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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Testosterone gel (FE 999093)

Subjects received testosterone gel with initial dose as fixed on Day 56 (23 mg, 46 mg or 69 mg) during the 000023 study. The dose could further be down titrated based on serum testosterone levels at Day 90/91 of 000023 study. Testosterone gel was applied daily in morning using an applicator, to the shoulder/upper arm in a contralateral fashion for 6 months.

Group Type EXPERIMENTAL

Testosterone Gel (FE 999093)

Intervention Type DRUG

Interventions

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Testosterone Gel (FE 999093)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completion of the Phase 3 protocol (NCT01665599)

Exclusion Criteria

* Use of another investigational product
* Use of any medications that could be considered anabolic or interfere with androgen metabolism
* Use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens, or human growth hormone
* Use of another testosterone product
* Chronic use of any drug of abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Medical Affiliated Research Center

Huntsville, Alabama, United States

Site Status

California Professional Research

Newport Beach, California, United States

Site Status

San Diego Sexual Medicine

San Diego, California, United States

Site Status

Connecticut Clinical Research

Middlebury, Connecticut, United States

Site Status

South Florida Medical Research

Aventura, Florida, United States

Site Status

Michigan Institute of Urology

Saint Clair Shores, Michigan, United States

Site Status

Premier Urology Associates

Lawrenceville, New Jersey, United States

Site Status

University Urology

New York, New York, United States

Site Status

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, United States

Site Status

PMG Research of Wilmington

Winston-Salem, North Carolina, United States

Site Status

Tristate Urologic Services

Cincinnati, Ohio, United States

Site Status

Omega Medical Research

Warwick, Rhode Island, United States

Site Status

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Site Status

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Site Status

Clinical Research Associates

Nashville, Tennessee, United States

Site Status

Urology Clinics of North Texas

Dallas, Texas, United States

Site Status

St. Joseph's Healthcare

London, Ontario, Canada

Site Status

Private Practice and Clinical Research

North Bay, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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000077

Identifier Type: -

Identifier Source: org_study_id