Trial · NCT00433199
Testosterone Treatment for Hypogonadal Men
NCT00433199, Phase 3, Completed, Abbott; results first posted 2011-12-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testosterone Treatment for Hypogonadal Men. Trials, record NCT00433199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00433199
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testosterone Treatment for Hypogonadal Men
- NCT number
- NCT00433199
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 274 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Hypogonadism
- Interventions
- Testosterone (T) Gel 1.62%, Placebo
- First posted
- 2007-02-09
- Last updated
- 2015-01-27
- Results first posted
- 2011-12-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112 | Day 112 | Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as \>=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results |
| Secondary | Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14 | Day 14 | Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as \>=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results |
| Secondary | Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56 | Day 56 | Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as \>=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results |
| Secondary | Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182 | Day 182 | Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as \>=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results. |
| Secondary | Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. | Day 266 | The success at Day 266 was defined as \>=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%. |
| Secondary | Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364. | Day 364 | The success at Day 364 was defined as \>=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112 | Day 112 | The analysis was done on the Full analysis sample defined as the subjects who were included in the Safety Sample and who had data for at least one post-Baseline assessment of any efficacy measurement up to and including Day 182 (double-blind period). The number correspond to the number of subjects having a measurement at Day 112; | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14 | Day 14 | The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 14. | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56 | Day 56 | The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 56. | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182 | Day 182 | The analysis was done on the Full analysis set with patients included in the double-blind period with a measurement at Day 182. | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. | Day 266 | The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 266. | Percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364. | Day 364 | The analysis was done on the Full analysis set with patients included in the open-label period with a measurement at Day 364. | Percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112 | T-Gel 1.62% | 81.6 | 95% Confidence Interval 75.1 to 87.0 | Percentage of subjects | |
| Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112 | Placebo | 37.0 | 95% Confidence Interval 19.4 to 57.6 | Percentage of subjects | |
| Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14 | T-Gel 1.62% | 65.7 | 95% Confidence Interval 58.9 to 72.1 | Percentage of subjects | |
| Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14 | Placebo | 29.7 | 95% Confidence Interval 15.9 to 47.0 | Percentage of subjects | |
| Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56 | T-Gel 1.62% | 82.5 | 95% Confidence Interval 76.2 to 87.7 | Percentage of subjects | |
| Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56 | Placebo | 34.4 | 95% Confidence Interval 18.6 to 53.2 | Percentage of subjects | |
| Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182 | T-Gel 1.62% | 82.2 | 95% Confidence Interval 75.6 to 87.7 | Percentage of subjects | |
| Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182 | Placebo | 28.6 | 95% Confidence Interval 13.2 to 48.7 | Percentage of subjects | |
| Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. | Continuing Active T-Gel 1.62% (CA) | 78.4 | 95% Confidence Interval 70.6 to 84.9 | Percentage of subjects | |
| Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266. | Formerly Placebo (FP) | 69.2 | 95% Confidence Interval 48.2 to 85.7 | Percentage of subjects |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Period | STARTED | Placebo | 40 | |
| Double-Blind Period | STARTED | T-Gel 1.62% | 234 | |
| Double-Blind Period | COMPLETED | Placebo | 28 | |
| Double-Blind Period | COMPLETED | T-Gel 1.62% | 168 | |
| Double-Blind Period | NOT COMPLETED | Placebo | 12 | |
| Double-Blind Period | NOT COMPLETED | T-Gel 1.62% | 66 | |
| Open-Label Period | STARTED | Placebo | 0 | |
| Open-Label Period | STARTED | T-Gel 1.62% | 219 | |
| Open-Label Period | COMPLETED | Placebo | 0 | |
| Open-Label Period | COMPLETED | T-Gel 1.62% | 185 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events20
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 | Bacterial infections NEC | Infections and infestations | Placebo | 2 | 40 | |
| other | Bacterial infections NEC | Infections and infestations | T-Gel 1.62% | 0 | 234 | |
| other | Upper respiratory tract infections | Infections and infestations | Placebo | 2 | 40 | |
| other | Upper respiratory tract infections | Infections and infestations | T-Gel 1.62% | 20 | 234 | |
| other | Cell marker procedures | Investigations | Placebo | 0 | 40 | |
| other | Cell marker procedures | Investigations | T-Gel 1.62% | 26 | 234 | |
| other | Headaches NEC | Nervous system disorders | Placebo | 2 | 40 | |
| other | Headaches NEC | Nervous system disorders | T-Gel 1.62% | 7 | 234 | |
| serious | Myocardial infarction | Cardiac disorders | Placebo | 0 | 40 | |
| serious | Myocardial infarction | Cardiac disorders | T-Gel 1.62% | 1 | 234 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | T-Gel 1.62% | ||
| Total, other adverse events | Placebo | 5 | 40 |
| Total, other adverse events | T-Gel 1.62% | 47 | 234 |
| Total, serious adverse events | Placebo | 1 | 40 |
| Total, serious adverse events | T-Gel 1.62% | 5 | 234 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22321357 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| T-Gel 1.62% vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00433199
GET https://conductscience.org/api/trials/v1/NCT00433199/registered