Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01665599
NCT01665599CompletedPhase 3

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 enrollmentStarted: July 2012Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
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
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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
  • •Hyperparathyroidism or uncontrolled diabetes
  • •Untreated moderate to severe depression
  • •History of testicular, prostate, or breast cancer
  • •HIV, Hepatitis B, or Hepatitis C positive
  • •PSA more or equal to 3 ng/mL
  • •Use of any medications that could be considered anabolic
  • •Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens, or human Growth Hormone
  • •Chronic use of any drug of abuse
  • •Involvement in a sport in which there is a screening for anabolic steroids
  • •Not willing to use adequate contraception during the study
  • •Partner is pregnant and/or breast feeding
  • •Partner has a history of breast, uterine or ovarian cancer

Arms & Interventions

Testosterone gel (FE 999303)

Experimental

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) (Drug)

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (19)

Loading locations...

Similar Trials

Completed
Phase 3
Open-Label Study of ARD-0403 in Testosterone Deficient MenHypogonadism
NCT00448955Ardana Bioscience Ltd150
Terminated
Phase 3
Open-Label Study of ARD-0403 in Testosterone Deficient MenHypogonadism
NCT00562731Ardana Bioscience Ltd150
Completed
Phase 3
A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) FormulationsHypogonadism
NCT00702650Eli Lilly and Company155
Completed
Phase 3
A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate CancerProstate Cancer
NCT03009981Alliance Foundation Trials, LLC.504
Completed
Phase 2
A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an ApplicatorHypogonadal Males
NCT01464879Ferring Pharmaceuticals20
A Clinical Trial to Evaluate the Efficacy... | Clinical Trial