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

Ferring Pharmaceuticals20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypogonadal Males

Interventions

Testosterone Gel (FE 999303)DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

AccuMed Research Associates

Garden City, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Days 15-21, Days 22-28 & Days 29-35

Secondary Outcomes

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.

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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