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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464879
First Posted: November 4, 2011
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ferring Pharmaceuticals
  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 Gel (FE 999303) Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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 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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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
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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01464879     History of Changes
Other Study ID Numbers: 000024
First Submitted: November 1, 2011
First Posted: November 4, 2011
Results First Submitted: June 29, 2017
Results First Posted: July 28, 2017
Last Update Posted: September 13, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents