Efficacy, Pharmacokinetics and Safety of Testosterone

Ferring

Status and phase: Completed; Phase 2

Conditions: Testicular Hypogonadism

Treatments: Drug: Testosterone gel (FE 99903)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01370369

000011

Details and patient eligibility

About

This is an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations < 297 ng/dL.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 18-65
• History of hypogonadism
• In good health based on medical history, physical examination and clinical laboratory tests
• Screening morning serum testosterone ≤ 297 ng/dL
• One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or reduced sexual functioning of non-vasculogenic or neurogenic nature)
• Body mass index (BMI) between 18 and 31

Exclusion criteria

• Prostate cancer
• Palpable prostatic mass(es)
• 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, finasteride, ketoconazole)
• Clinically significant anemia or renal dysfunction
• Hyperparathyroidism or uncontrolled diabetes
• Serum PSA Levels; ≥ 4ng/mL
• History of cardiovascular disease
• Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human growth hormone (hGH), (within previous 12 months)
• Use of testosterone products (within eight months for parenteral products, or six weeks for other preparations)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 6 patient groups

Single Testosterone Dose (Inner Thigh)

Experimental group

Description:

Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a seven day washout period.

Treatment:

Drug: Testosterone gel (FE 99903)

Single Testosterone Dose (Abdomen)

Experimental group

Description:

Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a seven day washout period.

Treatment:

Drug: Testosterone gel (FE 99903)

Single Testosterone Dose (shoulder/upper arm)

Experimental group

Description:

Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm.

Treatment:

Drug: Testosterone gel (FE 99903)

Testosterone 1.25

Experimental group

Description:

Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke) applied once daily for 10 consecutive days to the shoulder/upper arm.

Treatment:

Drug: Testosterone gel (FE 99903)

Testosterone 2.50

Experimental group

Description:

Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes) applied once daily for 10 consecutive days to the shoulder/upper arm.

Treatment:

Drug: Testosterone gel (FE 99903)

Testosterone 3.75

Experimental group

Description:

Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes) applied once daily for 10 consecutive days to the shoulder/upper arm.

Treatment:

Drug: Testosterone gel (FE 99903)