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Efficacy, Pharmacokinetics and Safety of Testosterone

This study has been completed.
Information provided by (Responsible Party):
Ferring Pharmaceuticals Identifier:
First received: June 1, 2011
Last updated: January 13, 2016
Last verified: January 2016
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 T concentrations < 297 ng/dL.

Condition Intervention Phase
Testicular Hypogonadism
Drug: Testosterone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label, Sequential Dose Escalation Study to Evaluate the Efficacy, Pharmacokinetics and Safety of Three Volumes of Topical Testosterone in Hypogonadal Males

Resource links provided by NLM:

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Responder Rate - the percentage of subjects whose Cmin and Cavg serum testosterone levels are between 298 and 1043 ng/dL [ Time Frame: From baseline to Day 43 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics (abdomen) - PK parameters, Cmax (ng/ml), t1/2 (hr), Tmax (ng/ml), AUC0-t (ng/ml*hr), will be calculated based on plasma concentrations of testosterone after an initial single treatment (testosterone) on the abdomen [ Time Frame: Days 1, 8 and 13 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (inner thigh) - PK parameters, Cmax (ng/ml), t1/2 (hr), Tmax (ng/ml), AUC0-t (ng/ml*hr), will be calculated based on plasma concentrations of testosterone after an initial single treatment (testosterone) on the inner thigh [ Time Frame: Days 1, 8 and 13 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (shoulders/upper arm) - PK parameters, Cmax (ng/ml), t1/2 (hr), Tmax (ng/ml), AUC0-t (ng/ml*hr), will be calculated based on plasma concentrations of testosterone after an initial single treatment (testosterone) on shoulders/upper arm [ Time Frame: Days 1, 8 and 13 ] [ Designated as safety issue: No ]
  • PK parameters - Cmax (ng/ml), t1/2 (hr), Tmax (ng/ml), AUC0-t (ng/ml*hr), for T, Free T and DHT; derived from plasma concentration versus time profiles to determine the multiple-dose profile of study drug after 10 days of treatment to shoulder/upper arm [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
  • Frequency of adverse events [ Time Frame: From baseline to Day 43 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Testosterone Topical Drug: Testosterone


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 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, GnRH agonists/antagonist, human GH (growth hormone), (within previous 12 months)
  • Use of testosterone products (within 8 months for parenteral products, or 6 weeks for other preparations)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01370369

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: NCT01370369     History of Changes
Other Study ID Numbers: 000011 
Study First Received: June 1, 2011
Last Updated: January 13, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
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 21, 2016