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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01464879
First received: November 1, 2011
Last updated: May 13, 2013
Last verified: May 2013

November 1, 2011
May 13, 2013
December 2011
May 2012   (final data collection date for primary outcome measure)
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 ]
Responder rate: percentage of patients whose Cavg serum testosterone levels are between 300 and 1050 ng/dL [ Time Frame: Baseline to Day 7 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01464879 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pharmacokinetic parameters (AUCτ, Tmax, Cmax, Cavg, Cmin, and T1/2) [ Time Frame: Days 7 and 21 (Visits 3 and 6) ] [ Designated as safety issue: No ]
  • Testosterone on hands after application, BEFORE hand washing [ Time Frame: Days 1 and 15 (Visits 2 and 5) ] [ Designated as safety issue: No ]
  • Testosterone on hands after application, AFTER hand washing [ Time Frame: Days 7 and 21 (Visits 3 and 6) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Clinical Trial to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator
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

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypogonadal Males
Drug: Testosterone (FE 999303)
  • Experimental: Testosterone Topical (hand)
    Intervention: Drug: Testosterone (FE 999303)
  • Experimental: Testosterone Topical (with an applicator)
    Intervention: Drug: Testosterone (FE 999303)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01464879
000024
No
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP