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Completed

NCT Number: NCT01464879

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

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

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Key information

Conditions

Hypogonadal Males

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

AccuMed Research Associates

Garden City, New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone gel (FE 999303)

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 4, 2011
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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