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

Ferring Pharmaceuticals160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Adult Male Hypogonadism

Interventions

Testosterone gel (FE 999303)DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (22)

Investigational site

Anniston, Alabama, United States

Investigational site

Huntsville, Alabama, United States

Outcomes

Primary Outcomes

The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL

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%.

Time frame: At Day 90

Secondary Outcomes

The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL

The data were presented using descriptive statistics. No statistical analysis was performed.

Time frame: At 14, 35 and 56

Change From Baseline in International Index of Erectile Function (IIEF) Score

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.

Time frame: At Days 35 and 90

Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score

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).

Data from ClinicalTrials.gov

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Investigational site

Newport Beach, California, United States

Investigational site

Denver, Colorado, United States

Investigational site

New Haven, Connecticut, United States

Investigational site

Aventura, Florida, United States

Investigational site

Clearwater, Florida, United States

Investigational site

Mishawaka, Indiana, United States

Investigational site

Watertown, Massachusetts, United States

Investigational site

Troy, Michigan, United States

...and 12 more locations

Time frame: At Days 35 and 90

Change From Baseline in Short Form-12 Health Survey (SF-12) Score

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.

Time frame: At Days 35 and 90

Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone

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.