Efficacy, Pharmacokinetics and Safety of Testosterone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01370369
First received: June 1, 2011
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370369

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

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01370369     History of Changes
Other Study ID Numbers: 000011
Study First Received: June 1, 2011
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on April 17, 2014