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Efficacy, Pharmacokinetics and Safety of Testosterone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370369
First Posted: June 9, 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 an open-label study of a single and repeated application of three dose levels of topical testosterone in hypogonadal males with morning serum testosterone concentrations < 297 ng/dL.

Condition Intervention Phase
Testicular Hypogonadism Drug: Testosterone gel (FE 99903) 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 to Evaluate the Efficacy, Pharmacokinetics and Safety of Three Volumes (1.25, 2.50 and 3.75 mL) of Testosterone Gel 2% (FE 999303) Equivalent to 23, 46 And 70 mg of Testosterone in Hypogonadal Males

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL. [ Time Frame: From Baseline to Day 43 ]
    Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome.


Secondary Outcome Measures:
  • Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13 ]
    The data were presented using descriptive statistics for this outcome.

  • Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13 ]
    The data were presented using descriptive statistics for this outcome.

  • Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13 ]
    The data were presented using descriptive statistics for this outcome.

  • Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 ]
    The data were presented using descriptive statistics for this outcome.

  • Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 ]
    The data were presented using descriptive statistics for this outcome.

  • Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 ]
    The data were presented using descriptive statistics for this outcome.

  • Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 ]
    The data were presented using descriptive statistics for this outcome.

  • Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 ]
    The data were presented using descriptive statistics for this outcome.

  • Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 ]
    The data were presented using descriptive statistics for this outcome.

  • Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 ]
    The data were presented using descriptive statistics for this outcome.

  • Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 ]
    The data were presented using descriptive statistics for this outcome.

  • Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm. [ Time Frame: Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43 ]
    The data were presented using descriptive statistics for this outcome.

  • Frequency of Adverse Events (AEs) [ Time Frame: From Baseline to Day 43 ]
    The data were presented using descriptive statistics for this outcome.


Enrollment: 20
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Testosterone Dose (Inner Thigh)
Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the inner thigh followed by a seven day washout period.
Drug: Testosterone gel (FE 99903)
Experimental: Single Testosterone Dose (Abdomen)
Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the abdomen followed by a seven day washout period.
Drug: Testosterone gel (FE 99903)
Experimental: Single Testosterone Dose (shoulder/upper arm)
Subjects received a single application of 2.50 mL (two strokes) of the testosterone gel 2% applied to the shoulder/upper arm.
Drug: Testosterone gel (FE 99903)
Experimental: Testosterone 1.25
Subjects received testosterone gel 2% at dose of 1.25 mL (one stroke) applied once daily for 10 consecutive days to the shoulder/upper arm.
Drug: Testosterone gel (FE 99903)
Experimental: Testosterone 2.50
Subjects received testosterone gel 2% at dose of 2.50 mL (two strokes) applied once daily for 10 consecutive days to the shoulder/upper arm.
Drug: Testosterone gel (FE 99903)
Experimental: Testosterone 3.75
Subjects received testosterone gel 2% at dose of 3.75 mL (three strokes) applied once daily for 10 consecutive days to the shoulder/upper arm.
Drug: Testosterone gel (FE 99903)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18-65
  • History of hypogonadism
  • In good health based on medical history, physical examination and clinical laboratory tests
  • Screening morning serum testosterone ≤ 297 ng/dL
  • One or more symptoms of testosterone deficiency (i.e. fatigue, reduced libido or reduced sexual functioning of non-vasculogenic or neurogenic nature)
  • Body mass index (BMI) between 18 and 31

Exclusion Criteria:

  • Prostate cancer
  • Palpable prostatic mass(es)
  • 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, finasteride, ketoconazole)
  • Clinically significant anemia or renal dysfunction
  • Hyperparathyroidism or uncontrolled diabetes
  • Serum PSA Levels; ≥ 4ng/mL
  • History of cardiovascular disease
  • Use of estrogens, Gonadotropin-releasing hormone (GnRH) agonists/antagonist, human growth hormone (hGH), (within previous 12 months)
  • Use of testosterone products (within eight months for parenteral products, or six weeks for other preparations)
  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): NCT01370369


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: NCT01370369     History of Changes
Other Study ID Numbers: 000011
First Submitted: June 1, 2011
First Posted: June 9, 2011
Results First Submitted: June 29, 2017
Results First Posted: August 1, 2017
Last Update Posted: September 13, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
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