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

Condition(s) targeted: Hypogonadal Males

Intervention: Testosterone (FE 999303) (Drug); Testosterone (FE 999303) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

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

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Responder rate: percentage of patients whose Cavg 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

Secondary outcome:

Responder rate: percentage of patients whose Cavg serum total testosterone levels are between 300 and 1050 ng/dL following treatment with one volume of FE 999303 applied by hand

Pharmacokinetics of total testosterone and DHT (dihydrotestosterone) measuring AUCτ, Tmax, Cmax, Cavg, Cmin, and T1/2

Pharmacokinetics of total testosterone and DHT (dihydrotestosterone) measuring AUCτ, Tmax, Cmax, Cavg, Cmin, and T1/2

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Male.

Criteria:

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

- 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

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

Starting date: December 2011
Last updated: May 13, 2013