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

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ClinicalTrials.gov Identifier: NCT01464879
Recruitment Status : Completed
First Posted : November 4, 2011
Results First Posted : July 28, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypogonadal Males Drug: Testosterone Gel (FE 999303) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Testosterone 2.50 mL (hand)
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by hand, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days.
 Drug: Testosterone Gel (FE 999303)
Experimental: Testosterone 1.25 mL (applicator)
Subjects in this arm self-applied one stroke (1.25 mL) of testosterone gel by applicator to the shoulder/upper arm every day for seven days.
 Drug: Testosterone Gel (FE 999303)
Experimental: Testosterone 2.50 mL (applicator)
Subjects in this arm self-applied two strokes (2.50 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm every day for seven days.
 Drug: Testosterone Gel (FE 999303)
Experimental: Testosterone 3.75 mL (applicator)
Subjects in this arm self-applied three strokes (3.75 mL) of testosterone gel by applicator, one stroke to the shoulder/upper arm and a second stroke to the contralateral shoulder/upper arm and a third stroke to the first shoulder/upper arm, every day for seven days.
 Drug: Testosterone Gel (FE 999303)


Outcome Measures
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Primary Outcome Measures :
  1. Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of 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 ]
    Descriptive statistics was used to present the outcome results.


Secondary Outcome Measures :
  1. Responder Rate: Percentage of Subjects 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 ]
  2. Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ) [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]
  3. Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax) [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]
  4. Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax) [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]
  5. Pharmacokinetics of Total Testosterone and DHT Measuring Cavg [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]
  6. Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin) [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]
  7. Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin) [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]
  8. Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]
  9. Pharmacokinetics of Total Testosterone and DHT Measuring Tmax [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]
  10. Pharmacokinetics of Total Testosterone and DHT Measuring Cmax [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]
  11. Pharmacokinetics of Total Testosterone and DHT Measuring Cavg [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]
  12. Pharmacokinetics of Total Testosterone and DHT Measuring Cmin [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]
  13. Pharmacokinetics of Total Testosterone and DHT Measuring Tmin [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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 kg/m^2
  • 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464879


Locations
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United States, New York
AccuMed Research Associates
Garden City, New York, United States
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01464879    
Other Study ID Numbers: 000024
First Posted: November 4, 2011    Key Record Dates
Results First Posted: July 28, 2017
Last Update Posted: September 13, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs