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
  Purpose

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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464879

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: 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:
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014