Trial · NCT01703741
A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
NCT01703741, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2017-10-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel. Trials, record NCT01703741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01703741
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
- NCT number
- NCT01703741
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 145 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Adult Male Hypogonadism
- Interventions
- Testosterone Gel (FE 999093)
- First posted
- 2012-10-10
- Last updated
- 2017-10-06
- Results first posted
- 2017-10-06
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) | Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. |
| Secondary | Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL. | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) | Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. |
| Secondary | Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire | At Month 6 | Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains are: 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 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain. |
| Secondary | Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire | At Month 6 | In ADAM questionnaire, subjects had to respond in "yes or no" to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer ("yes") to questions 1 or 7, or to any 3 other questions. The data were presented using descriptive statistics. |
| Secondary | Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire | At Month 6 | 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 is categorical and was 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 scores of 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. Range of GFI: 1 (no fatigue) to 50 (severe fatigue). The data were presented using descriptive statistics. |
| Secondary | Domain Scores for the Short Form-12 (SF-12) Questionnaire | At Month 6 | Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains: PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item) MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item) The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The data were presented using descriptive statistics. |
| Secondary | Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL | At Month 3 | The data were presented using descriptive statistics. |
| Secondary | Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL | At Month 6 | The data were presented using descriptive statistics. |
| Secondary | Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. |
| Secondary | Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) | Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6. The data were presented using descriptive statistics. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL. | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | percentage of subjects | NUMBER |
| SECONDARY | Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire | At Month 6 | ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available IIEF questionnaire results. | units on a scale | MEAN |
| SECONDARY | Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire | At Month 6 | ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available ADAM questionnaire results. | percentage of subjects | NUMBER |
| SECONDARY | Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire | At Month 6 | ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available MAF questionnaire results. | units on a scale | MEAN |
| SECONDARY | Domain Scores for the Short Form-12 (SF-12) Questionnaire | At Month 6 | ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available SF-12 questionnaire results. | units on a scale | MEAN |
| SECONDARY | Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL | At Month 3 | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL | At Month 6 | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | percentage of subjects | NUMBER |
| SECONDARY | Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | ng*hr/dL | MEAN |
| SECONDARY | Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone | Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month) | PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations. | hour | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group71
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL | Testosterone Gel (FE 999303) | Total testosterone level between 1500-1799 ng/dL | 5.7 | percentage of subjects | |
| Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL | Testosterone Gel (FE 999303) | Total testosterone level between 1800-2499 ng/dL | 2.8 | percentage of subjects | |
| Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL | Testosterone Gel (FE 999303) | Total testosterone level above 2500 ng/dL | 2.8 | percentage of subjects | |
| Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL. | Testosterone Gel (FE 999303) | 82.1 | percentage of subjects | ||
| Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire | Testosterone Gel (FE 999303) | Erectile function domain | 19.8 | Standard Deviation 7.9 | units on a scale |
| Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire | Testosterone Gel (FE 999303) | Orgasmic function domain | 7.3 | Standard Deviation 3.2 | units on a scale |
| Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire | Testosterone Gel (FE 999303) | Sexual desire domain | 7.0 | Standard Deviation 1.8 | units on a scale |
| Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire | Testosterone Gel (FE 999303) | Intercourse satisfaction domain | 8.7 | Standard Deviation 4.4 | units on a scale |
| Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire | Testosterone Gel (FE 999303) | Overall satisfaction domain | 6.7 | Standard Deviation 2.3 | units on a scale |
| Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire | Testosterone Gel (FE 999303) | 44.1 | percentage of subjects |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Testosterone Gel (FE 999303) | 145 | |
| Overall Study | Per Protocol (PP) Population | Testosterone Gel (FE 999303) | 106 | |
| Overall Study | COMPLETED | Testosterone Gel (FE 999303) | 127 | |
| Overall Study | NOT COMPLETED | Testosterone Gel (FE 999303) | 18 |
Source ClinicalTrials.gov
Adverse events40
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 | Ventricular extrasystoles | Cardiac disorders | Testosterone Gel (FE 999303) | 1 | 145 | |
| other | Dyspepsia | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 145 | |
| other | Gastrointestinal haemorrhage | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 145 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 145 | |
| other | Periodontal disease | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 145 | |
| other | Bronchitis | Infections and infestations | Testosterone Gel (FE 999303) | 1 | 145 | |
| other | Orchitis | Infections and infestations | Testosterone Gel (FE 999303) | 1 | 145 | |
| other | Pneumonia | Infections and infestations | Testosterone Gel (FE 999303) | 1 | 145 | |
| other | Contusion | Injury, poisoning and procedural complications | Testosterone Gel (FE 999303) | 1 | 145 | |
| other | Meniscus lesion | Injury, poisoning and procedural complications | Testosterone Gel (FE 999303) | 1 | 145 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 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) | 28 | 145 |
| Total, serious adverse events | Testosterone Gel (FE 999303) | 1 | 145 |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01703741/results?page=2