A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator

A Phase 2, Open-Label, Sequential Dose Escalation Study in Adult Hypogonadal Males to Evaluate the Pharmacokinetics of Three Volumes of FE 999303 (Testosterone Gel), Applied to the Shoulder/Upper Arm, Using an Applicator Compared With Hand Application

This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations <300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand application

Study Overview

• Status: Completed
• Conditions: Hypogonadal Males
• Intervention / Treatment: Drug: Testosterone Gel (FE 999303)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Garden City, New York, United States
      • AccuMed Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Ages 18-75
• History of hypogonadism
• In good health based on medical history, physical examination, and clinical laboratory tests
• Serum testosterone deficiency
• One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)
• Body mass index (BMI) between 18 and 35 kg/m^2
• All screening lab tests within 20% of the normal range (exceptions are liver function tests)
• HIV, Hepatitis B and C negative

Exclusion Criteria:

• Previous use of FE 999303
• Prostate cancer
• Breast carcinoma, patient or partner
• Palpable prostatic mass(es)
• Serum PSA levels ≥3 ng/dL
• Chronic use of any drug of abuse
• Lower urinary tract obstruction
• Clinically significant anemia or renal dysfunction
• Cardiovascular disease
• Hyperparathyroidism or uncontrolled diabetes
• Generalized skin irritation or significant skin disease
• Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
• Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening)
• Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations)
• Sleep apnea
• Untreated depression
• Subject with a partner who is pregnant or will not use contraception

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Testosterone 2.50 mL (hand); Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days.	Drug: Testosterone Gel (FE 999303)
Experimental: Testosterone 1.25 mL (applicator); Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm every day for seven days.	Drug: Testosterone Gel (FE 999303)
Experimental: Testosterone 2.50 mL (applicator); Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days.	Drug: Testosterone Gel (FE 999303)
Experimental: Testosterone 3.75 mL (applicator); Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, every day for seven days.	Drug: Testosterone Gel (FE 999303)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.	Descriptive statistics was used to present the outcome results.	Days 15-21, Days 22-28 & Days 29-35

Secondary Outcome Measures

Outcome Measure	Time Frame
Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.	Days 1-7
Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator
Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Tmax	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Cmax	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Cavg	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Cmin	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand
Pharmacokinetics of Total Testosterone and DHT Measuring Tmin	Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: November 1, 2011
• First Submitted That Met QC Criteria: November 3, 2011
• First Posted (Estimate): November 4, 2011

Study Record Updates

• Last Update Posted (Actual): September 13, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: 000024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No