Completed
A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
What is being tested
Testosterone gel (FE 999303)
Drug
Who is being recruted
Endocrine System Diseases+1
+ Gonadal Disorders
+ Hypogonadism
From 18 to 75 Years
+25 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: July 2012
Summary
Principal SponsorFerring Pharmaceuticals
Last updated: October 26, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.
Principal SponsorFerring Pharmaceuticals
Last updated: October 26, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
180 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Endocrine System DiseasesGonadal DisordersHypogonadismEunuchism
Criteria
3 inclusion criteria required to participate
Males between 18-75 years of age
One or more symptoms of testosterone deficiency
Two screening serum testosterone values less than 300 ng/dL
22 exclusion criteria prevent from participating
BMI less than 18 kg/m^2 or more than 35 kg/m^2
Chronic use of any drug of abuse
Generalized skin irritation or skin disease
HIV, Hepatitis B, or Hepatitis C positive
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalSubjects received a starting dose of 46 mg (two actuations) of testosterone gel (2%) daily in the morning. The dose was further titrated (increased or decreased - three actuations [69 mg] or single actuation [23 mg], respectively) based on serum testosterone concentrations.
Testosterone gel was applied using an applicator, to the shoulder/upper arm in a contralateral fashion.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 19 locations
Medical Affiliated Research Cente
Huntsville, United StatesOpen Medical Affiliated Research Cente in Google MapsCalifornia Professional Research
Newport Beach, United StatesSan Diego Sexual Medicine
San Diego, United StatesConnecticut Clinical Research
Middlebury, United StatesCompleted19 Study Centers