Trial · NCT00522431
A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
NCT00522431, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2014-03-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone. Trials, record NCT00522431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00522431
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
- NCT number
- NCT00522431
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 149 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Hypogonadism
- Interventions
- Testosterone
- First posted
- 2007-08-29
- Last updated
- 2017-10-05
- Results first posted
- 2014-03-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 | 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 | Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL |
| Secondary | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 | 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 | Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and \>2500 ng/dL |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 | 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 | Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 | 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 | Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 | Fortigel | 77.5 | 95% Confidence Interval 70.3 to 94.7 | percentage of participants | |
| Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 | Fortigel | ≤1500 ng/dL | 94.6 | percentage of participants | |
| Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 | Fortigel | 1800-2500 ng/dL | 1.6 | percentage of participants | |
| Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 | Fortigel | >2500 ng/dL | 0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fortigel | 149 | |
| Overall Study | COMPLETED | Fortigel | 138 | |
| Overall Study | NOT COMPLETED | Fortigel | 11 |
Source ClinicalTrials.gov
Adverse events23
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 | Skin reaction | Skin and subcutaneous tissue disorders | Fortigel | 25 | 149 | |
| other | Rash | Skin and subcutaneous tissue disorders | Fortigel | 2 | 149 | |
| other | Upper respiratory tract infection | Infections and infestations | Fortigel | 10 | 149 | |
| other | Sinusitis | Infections and infestations | Fortigel | 6 | 149 | |
| other | Cellulitis | Infections and infestations | Fortigel | 2 | 149 | |
| other | Diarrhoea | Gastrointestinal disorders | Fortigel | 3 | 149 | |
| other | Vomiting | Gastrointestinal disorders | Fortigel | 3 | 149 | |
| other | Abdominal pain | Gastrointestinal disorders | Fortigel | 2 | 149 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Fortigel | 2 | 149 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Fortigel | 2 | 149 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fortigel | ||
| Total, other adverse events | Fortigel | 67 | 149 |
| Total, serious adverse events | Fortigel | 5 | 149 |
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/NCT00522431
GET https://conductscience.org/api/trials/v1/NCT00522431/events?page=2