A Phase 3, Open-label, Non-randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males

Ferring Pharmaceuticals19 sites in 2 countries180 target enrollmentJuly 2012

ConditionsAdult Male Hypogonadism

InterventionsTestosterone gel (FE 999303)

DrugsTestosterone gel (FE 999303)

Overview

Phase: Phase 3
Intervention: Testosterone gel (FE 999303)
Conditions: Adult Male Hypogonadism
Sponsor: Ferring Pharmaceuticals
Enrollment: 180
Locations: 19
Primary Endpoint: The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

May 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Ferring Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males between 18-75 years of age
•Two screening serum testosterone values less than 300 ng/dL
•One or more symptoms of testosterone deficiency

Exclusion Criteria

•Previous use of the investigational product
•Use of any investigational product within 30 days prior to screening and during the study
•BMI less than 18 kg/m\^2 or more than 35 kg/m\^2
•Prostatic mass(es)
•Generalized skin irritation or skin disease
•Lower urinary tract obstruction
•Myocardial infarction or cerebrovascular accident in the last 6 months
•Unstable angina or congestive heart failure
•Thromboembolic disorders
•Sleep apnea

Arms & Interventions

Testosterone gel (FE 999303)

Subjects 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.

Intervention: Testosterone gel (FE 999303)

Outcomes

Primary Outcomes

The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL

Time Frame: Day 90

The data were presented using descriptive statistics. No statistical analysis was performed.

Secondary Outcomes

Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)(Day 1; Day 90)
Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)(Day 1; Day 90)
Pharmacokinetics of DHT Measuring Tmax(Day 1; Day 90)
Pharmacokinetics of DHT Measuring Cmax(Day 1; Day 90)
The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL(Day 1)
Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)(Day 1; Day 90)
Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)(Day 1; Day 90)
Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ(Day 1; Day 90)
Pharmacokinetics of DHT Measuring Cave(Day 1; Day 90)
Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)(Day 1; Day 90)
Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)(Day 1; Day 90)
Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire(Day 91)
Pharmacokinetics of DHT Measuring Cmin(Day 1; Day 90)
Pharmacokinetics of DHT Measuring Tmin(Day 1; Day 90)
Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire(Day 91)
Change From Baseline in the SF-12 Health Questionnaire(Day 91)