A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

NCT01703741 | Completed Phase 3 Results

• 1 other identifier: 000077
• Study Type: interventional
• Target: 145
• Locations: 2 countries
• Sites: 18

Brief Summary

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.

Conditions

Adult Male Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL

  Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics.

  Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)

Secondary Outcomes (12)

• Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.

  Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)

• Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire

  At Month 6

• Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire

  At Month 6

• Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire

  At Month 6

• Domain Scores for the Short Form-12 (SF-12) Questionnaire

  At Month 6

Study Arms (1)

Testosterone gel (FE 999093)

EXPERIMENTAL

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.

Drug: Testosterone Gel (FE 999093)

Interventions

Testosterone Gel (FE 999093) DRUG

Testosterone gel (FE 999093)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion of the Phase 3 protocol (NCT01665599)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (18)

Medical Affiliated Research Center

Huntsville, Alabama, United States

Location

California Professional Research

Newport Beach, California, United States

Location

San Diego Sexual Medicine

San Diego, California, United States

Location

Connecticut Clinical Research

Middlebury, Connecticut, United States

Location

South Florida Medical Research

Aventura, Florida, United States

Location

Michigan Institute of Urology

Saint Clair Shores, Michigan, United States

Location

Premier Urology Associates

Lawrenceville, New Jersey, United States

Location

University Urology

New York, New York, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, United States

Location

PMG Research of Wilmington

Winston-Salem, North Carolina, United States

Location

Tristate Urologic Services

Cincinnati, Ohio, United States

Location

Omega Medical Research

Warwick, Rhode Island, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Location

Clinical Research Associates

Nashville, Tennessee, United States

Location

Urology Clinics of North Texas

Dallas, Texas, United States

Location

St. Joseph's Healthcare

London, Ontario, Canada

Location

Private Practice and Clinical Research

North Bay, Ontario, Canada

Location

MeSH Terms

Conditions

Eunuchism

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 10, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 6, 2017
• Results First Posted: October 6, 2017

Record last verified: 2017-09

Locations

US (16); CA (2)