Efficacy, Pharmacokinetics and Safety of Testosterone

NCT ID: NCT01370369

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-07-31

Brief Summary

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.

Conditions

Testicular Hypogonadism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Testosterone Dose (Inner Thigh)

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.

Group Type: EXPERIMENTAL

Testosterone gel (FE 99903)

Intervention Type: DRUG

Single Testosterone Dose (Abdomen)

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.

Group Type: EXPERIMENTAL

Testosterone gel (FE 99903)

Intervention Type: DRUG

Single Testosterone Dose (shoulder/upper arm)

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

Group Type: EXPERIMENTAL

Testosterone gel (FE 99903)

Intervention Type: DRUG

Testosterone 1.25

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.

Group Type: EXPERIMENTAL

Testosterone gel (FE 99903)

Intervention Type: DRUG

Testosterone 2.50

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.

Group Type: EXPERIMENTAL

Testosterone gel (FE 99903)

Intervention Type: DRUG

Testosterone 3.75

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.

Group Type: EXPERIMENTAL

Testosterone gel (FE 99903)

Intervention Type: DRUG

Interventions

Testosterone gel (FE 99903)

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

AccuMed Research Associates

Garden City, New York, United States

Countries

United States

Other Identifiers

000011

Identifier Type: -

Identifier Source: org_study_id