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A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males

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ClinicalTrials.gov Identifier: NCT02149264
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : July 28, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.

Condition or disease Intervention/treatment Phase
Adult Male Hypogonadism Drug: Testosterone gel (FE 999303) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Non-Randomized, Clinical Trial to Evaluate the Efficacy and Safety of FE 999303 (Testosterone Gel) in Adult Hypogonadal Males
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Testosterone gel (FE 999303)
Subjects received at least one dose of testosterone gel (23 mg), which was further titrated, if needed (upto three doses [69 mg]), based on serum testosterone concentrations. Testosterone gel was delivered using an applicator to the contralateral shoulder/upper arm.
Drug: Testosterone gel (FE 999303)



Primary Outcome Measures :
  1. The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL [ Time Frame: At Day 90 ]
    The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.


Secondary Outcome Measures :
  1. The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL [ Time Frame: At 14, 35 and 56 ]
    The data were presented using descriptive statistics. No statistical analysis was performed.

  2. Change From Baseline in International Index of Erectile Function (IIEF) Score [ Time Frame: At Days 35 and 90 ]

    Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains were:

    1. Erectile function (6 items, questions 1-5 and 15) (Score range:1-30)
    2. Orgasmic function (2 items, questions 9-10) (Score range: 0-10)
    3. Sexual desire (2 items, questions 11-12) (Score range: 2-10)
    4. Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)
    5. Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)

    A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function.


  3. Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score [ Time Frame: At Days 35 and 90 ]

    The MAF contains four sub-domains:

    1. Severity (2 items, questions 1-2) (Score range: 2-20)
    2. Distress (1 item, question 3) (Score range: 1-10)
    3. Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)
    4. Timing (2 items, questions 15-16) (Score range: 5-20)

    A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain (categorical in nature) are scored from 1-4. The scores are converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.

    To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue).


  4. Change From Baseline in Short Form-12 Health Survey (SF-12) Score [ Time Frame: At Days 35 and 90 ]

    Data collected from the SF-12 questionnaire, based on the norm-based scores was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contained four sub-domains:

    PCS:

    1. Physical Functioning (2 items, questions 2-3)
    2. Role-Physical (2 items, questions 4-5)
    3. Bodily Pain (1 item, question 8)
    4. General Health (1 item, question 1)

    MCS:

    1. Vitality (1 item, question 10)
    2. Social Functioning (1 item, question 12)
    3. Role-Emotional (2 items, questions 6-7)
    4. Mental Health (2 items, questions 9 and 11)

    PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicated improvement in physical and mental health.


  5. Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone [ Time Frame: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 ]
    A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone and dihydrotestosterone.

  6. Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone [ Time Frame: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 ]
    A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.

  7. Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone [ Time Frame: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 ]
    A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.

  8. Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone [ Time Frame: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 ]
    A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.

  9. Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone [ Time Frame: Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90 ]
    A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.



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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:

  • Males between 18-75 years of age
  • Two fasting serum testosterone levels <300 ng/dL

Exclusion Criteria:

  • Previous use of the study drug
  • History of prostate or breast cancer
  • Prostate-Specific Antigen (PSA) ≥3 ng/mL
  • Subject is sexually active and not willing to use adequate contraception

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): NCT02149264


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Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02149264     History of Changes
Other Study ID Numbers: 000127
First Posted: May 29, 2014    Key Record Dates
Results First Posted: July 28, 2017
Last Update Posted: October 26, 2017
Last Verified: September 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