Trial · NCT01665599
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
NCT01665599, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2017-09-20
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. Trials, record NCT01665599. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01665599
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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
- NCT number
- NCT01665599
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 180 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Adult Male Hypogonadism
- Interventions
- Testosterone gel (FE 999303)
- First posted
- 2012-08-15
- Last updated
- 2017-10-26
- Results first posted
- 2017-09-20
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL | Day 90 | The data were presented using descriptive statistics. No statistical analysis was performed. |
| Secondary | The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL | Day 1 | The data were presented using descriptive statistics. No statistical analysis was performed. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ) | Day 1; 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. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax) | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of total testosterone. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax) | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of total testosterone. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave) | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of total testosterone. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin) | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of total testosterone. |
| Secondary | Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin) | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of total testosterone. |
| Secondary | Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of DHT. |
| Secondary | Pharmacokinetics of DHT Measuring Tmax | Day 1; Day 90 | A validated LC/MS/MS method was used to determine the levels of DHT. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL | Day 90 | Full Analysis set (FAS) population was used which comprised of subjects who had any available pharmacokinetic (PK) data for testosterone on Day 90. | percentage of participants | NUMBER |
| SECONDARY | The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL | Day 1 | FAS population was used which comprised of subjects who had any available PK data for testosterone on Day 90. | percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ) | Day 1; Day 90 | ITT population was used which comprised of all participants who received at least one dose of IMP. | ng*hr/dL | MEAN |
| SECONDARY | Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax) | Day 1; Day 90 | ITT population was used which comprised of all participants who received at least one dose of IMP. | hour | MEDIAN |
| SECONDARY | Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax) | Day 1; Day 90 | ITT population was used which comprised of all participants who received at least one dose of IMP. | ng/dL | MEAN |
| SECONDARY | Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave) | Day 1; Day 90 | ITT population was used which comprised of all participants who received at least one dose of IMP. | ng/dL | MEAN |
| SECONDARY | Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin) | Day 1; Day 90 | ITT population was used which comprised of all participants who received at least one dose of IMP. | ng/dL | MEAN |
| SECONDARY | Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin) | Day 1; Day 90 | ITT population was used which comprised of all participants who received at least one dose of IMP. | hour | MEDIAN |
| SECONDARY | Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ | Day 1; Day 90 | ITT population was used which comprised of all participants who received at least one dose of IMP. | ng*hr/dL | MEAN |
| SECONDARY | Pharmacokinetics of DHT Measuring Tmax | Day 1; Day 90 | ITT population was used which comprised of all participants who received at least one dose of IMP. | hour | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group73
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 on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL | Testosterone Gel (FE 999303) | 23 mg | 2.9 | percentage of participants | |
| The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL | Testosterone Gel (FE 999303) | 46 mg | 4.7 | percentage of participants | |
| The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL | Testosterone Gel (FE 999303) | 69 mg | 77.9 | percentage of participants | |
| The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL | Testosterone Gel (FE 999303) | Overall | 85.5 | percentage of participants | |
| The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL | Testosterone Gel (FE 999303) | 51.7 | percentage of participants | ||
| Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ) | Testosterone Gel (FE 999303) | Day 1; 46 mg (n=180) | 7,616 | Standard Deviation 2,242 | ng*hr/dL |
| Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ) | Testosterone Gel (FE 999303) | Day 90; 23 mg (n=5) | 12,433 | Standard Deviation 3,100 | ng*hr/dL |
| Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ) | Testosterone Gel (FE 999303) | Day 90; 46 mg (n=12) | 9,835 | Standard Deviation 3,831 | ng*hr/dL |
| Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ) | Testosterone Gel (FE 999303) | Day 90; 69 mg (n=155) | 11,967 | Standard Deviation 4,439 | ng*hr/dL |
| Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ) | Testosterone Gel (FE 999303) | Day 90; all doses (n=172) | 11,825 | Standard Deviation 4,382 | ng*hr/dL |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 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) | 180 | |
| Overall Study | COMPLETED | Testosterone Gel (FE 999303) | 172 | |
| Overall Study | NOT COMPLETED | Testosterone Gel (FE 999303) | 8 |
Source ClinicalTrials.gov
Adverse events73
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 | Abdominal discomfort | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 180 | |
| other | Abdominal pain | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 180 | |
| other | Abdominal pain lower | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 180 | |
| other | Colonic polyp | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 180 | |
| other | Constipation | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 180 | |
| other | Pancreatitis chronic | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 180 | |
| other | Toothache | Gastrointestinal disorders | Testosterone Gel (FE 999303) | 1 | 180 | |
| other | Chest pain | General disorders | Testosterone Gel (FE 999303) | 1 | 180 | |
| other | Inflammation | General disorders | Testosterone Gel (FE 999303) | 1 | 180 | |
| other | Pyrexia | General disorders | Testosterone Gel (FE 999303) | 1 | 180 |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 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) | 62 | 180 |
| Total, serious adverse events | Testosterone Gel (FE 999303) | 3 | 180 |
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.
GET https://conductscience.org/api/trials/v1/NCT01665599
GET https://conductscience.org/api/trials/v1/NCT01665599/results?page=2