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

Ferring

Status and phase: Completed; Phase 2

Conditions: Hypogonadal Males

Treatments: Drug: Testosterone Gel (FE 999303)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464879

000024

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Testosterone 2.50 mL (hand)

Experimental group

Description:

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.

Treatment:

Drug: Testosterone Gel (FE 999303)

Testosterone 1.25 mL (applicator)

Experimental group

Description:

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.

Treatment:

Drug: Testosterone Gel (FE 999303)

Testosterone 2.50 mL (applicator)

Experimental group

Description:

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.

Treatment:

Drug: Testosterone Gel (FE 999303)

Testosterone 3.75 mL (applicator)

Experimental group

Description:

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.

Treatment:

Drug: Testosterone Gel (FE 999303)