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

This study has been completed.
Information provided by (Responsible Party):
Ferring Pharmaceuticals Identifier:
First received: November 1, 2011
Last updated: May 13, 2013
Last verified: May 2013
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

Condition Intervention Phase
Hypogonadal Males
Drug: Testosterone (FE 999303)
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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 [ Time Frame: Days 15-21, Days 22-28 & Days 29-35 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of total testosterone and DHT (dihydrotestosterone) measuring AUCτ, Tmax, Cmax, Cavg, Cmin, and T1/2 [ Time Frame: Day 21, 28 & 35 (applicator) ] [ Designated as safety issue: No ]
  • Pharmacokinetics of total testosterone and DHT (dihydrotestosterone) measuring AUCτ, Tmax, Cmax, Cavg, Cmin, and T1/2 [ Time Frame: Day 7 (hand) ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Testosterone Topical (hand) Drug: Testosterone (FE 999303)
Experimental: Testosterone Topical (with an applicator) Drug: Testosterone (FE 999303)


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01464879

United States, New York
AccuMed Research Associates
Garden City, New York, United States
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01464879     History of Changes
Other Study ID Numbers: 000024 
Study First Received: November 1, 2011
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on October 27, 2016