Trial · NCT02149264
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
NCT02149264, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2017-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males. Trials, record NCT02149264. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02149264
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
- NCT number
- NCT02149264
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 160 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Adult Male Hypogonadism
- Interventions
- Testosterone gel (FE 999303)
- First posted
- 2014-05-29
- Last updated
- 2017-10-26
- Results first posted
- 2017-07-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | 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 | The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | At 14, 35 and 56 | The data were presented using descriptive statistics. No statistical analysis was performed. |
| Secondary | Change From Baseline in International Index of Erectile Function (IIEF) Score | 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. |
| Secondary | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score | 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). |
| Secondary | Change From Baseline in Short Form-12 Health Survey (SF-12) Score | 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. |
| Secondary | Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone | 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. |
| Secondary | Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone | 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. |
| Secondary | Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone | 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. |
| Secondary | Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone | 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. |
| Secondary | Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | At Day 90 | Full Analysis Set (FAS) population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. | percentage of subjects | NUMBER |
| SECONDARY | The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | At 14, 35 and 56 | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. | percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in International Index of Erectile Function (IIEF) Score | At Days 35 and 90 | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score | At Days 35 and 90 | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Short Form-12 Health Survey (SF-12) Score | At Days 35 and 90 | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. | units on a scale | MEAN |
| SECONDARY | Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone | 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 | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point. | ng/dL | MEAN |
| SECONDARY | Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone | 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 | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point. | ng*hr/dL | MEAN |
| SECONDARY | Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone | 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 | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to adverse event after Day 14 visit and not included in the analysis. | hr | MEDIAN |
| SECONDARY | Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone | 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 | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis. | ng/dL | MEAN |
| SECONDARY | Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone | 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 | FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis. | ng/dL | MEAN |
Source ClinicalTrials.gov
Results by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | Testosterone Gel (FE 999303) | 76.1 | 95% Confidence Interval 69.4 to 82.8 | percentage of subjects | |
| The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | Testosterone Gel (FE 999303) | Day 14 | 29.1 | percentage of subjects | |
| The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | Testosterone Gel (FE 999303) | Day 35 | 58.2 | percentage of subjects | |
| The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL | Testosterone Gel (FE 999303) | Day 56 | 71.2 | percentage of subjects | |
| Change From Baseline in International Index of Erectile Function (IIEF) Score | Testosterone Gel (FE 999303) | Day 35 | 8.4 | Standard Deviation 13.2 | units on a scale |
| Change From Baseline in International Index of Erectile Function (IIEF) Score | Testosterone Gel (FE 999303) | Day 90 | 14.4 | Standard Deviation 16.9 | units on a scale |
| Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score | Testosterone Gel (FE 999303) | Severity domain score at Day 35 | -3.6 | Standard Deviation 4.8 | units on a scale |
| Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score | Testosterone Gel (FE 999303) | Distress domain score at Day 35 | -1.7 | Standard Deviation 2.6 | units on a scale |
| Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score | Testosterone Gel (FE 999303) | Degree of interference domain score at Day 35 | -13.6 | Standard Deviation 24.1 | units on a scale |
| Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score | Testosterone Gel (FE 999303) | Timing domain score at Day 35 | -2.6 | Standard Deviation 3.3 | units on a scale |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Testosterone Gel (FE 999303) | 159 | |
| Overall Study | COMPLETED | Testosterone Gel (FE 999303) | 139 | |
| Overall Study | NOT COMPLETED | Testosterone Gel (FE 999303) | 20 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hydrocele | Congenital, familial and genetic disorders | Testosterone Gel (FE 999303) | 1 | 159 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 159 | |
| other | Nausea | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 2 | 159 | |
| other | Toothache | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 159 | |
| other | Application site dermatitis | General disorders | Testosterone Gel (FE 999303) | 1 | 159 | |
| other | Application site erythema | General disorders | Testosterone Gel (FE 999303) | 4 | 159 | |
| other | Application site pruritus | General disorders | Testosterone Gel (FE 999303) | 1 | 159 | |
| other | Application site rash | General disorders | Testosterone Gel (FE 999303) | 3 | 159 | |
| other | Cyst | General disorders | Testosterone Gel (FE 999303) | 1 | 159 | |
| other | Fatigue | General disorders | Testosterone Gel (FE 999303) | 1 | 159 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Testosterone Gel (FE 999303) | ||
| Total, other adverse events | Testosterone Gel (FE 999303) | 54 | 159 |
| Total, serious adverse events | Testosterone Gel (FE 999303) | 5 | 159 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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