MedDataX Logo

A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males

NCT ID: NCT02149264

Last Updated: 2017-10-26

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adult Male Hypogonadism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Testosterone gel (FE 999303)

Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses \[69 mg\]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.

Group Type EXPERIMENTAL

Testosterone gel (FE 999303)

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Testosterone gel (FE 999303)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males between 18-75 years of age
* Two fasting serum testosterone levels \<300 ng/dL

Exclusion Criteria

* Previous use of the study drug
* History of prostate or breast cancer
* Prostate-Specific Antigen (PSA) ≥3 ng/mL
* Subject is sexually active and not willing to use adequate contraception
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Investigational site

Anniston, Alabama, United States

Site Status

Investigational site

Huntsville, Alabama, United States

Site Status

Investigational site

Newport Beach, California, United States

Site Status

Investigational site

Denver, Colorado, United States

Site Status

Investigational site

New Haven, Connecticut, United States

Site Status

Investigational site

Aventura, Florida, United States

Site Status

Investigational site

Clearwater, Florida, United States

Site Status

Investigational site

Mishawaka, Indiana, United States

Site Status

Investigational site

Watertown, Massachusetts, United States

Site Status

Investigational site

Troy, Michigan, United States

Site Status

Investigational site

Edison, New Jersey, United States

Site Status

Investigational site

Lawrence, New Jersey, United States

Site Status

Investigational site

Garden City, New York, United States

Site Status

Investigational site

New York, New York, United States

Site Status

Investigational site

Poughkeepsie, New York, United States

Site Status

Investigational site

Purchase, New York, United States

Site Status

Investigational site

Bala-Cynwyd, Pennsylvania, United States

Site Status

Investigational site

Warwick, Rhode Island, United States

Site Status

Investigational site

Mt. Pleasant, South Carolina, United States

Site Status

Investigational site

Nashville, Tennessee, United States

Site Status

Investigational site

Webster, Texas, United States

Site Status

Investigational site

Norfolk, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

000127

Identifier Type: -

Identifier Source: org_study_id