Trial · NCT01403116
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
NCT01403116, Phase 3, Completed, Clarus Therapeutics, Inc.; results first posted 2018-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men. Trials, record NCT01403116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01403116
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
- NCT number
- NCT01403116
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 325 participants, actual
- Lead sponsor
- Clarus Therapeutics, Inc.
- Conditions
- Male Hypogonadism
- Interventions
- Oral testosterone undecanoate, topical testosterone gel
- First posted
- 2011-07-27
- Last updated
- 2018-08-14
- Results first posted
- 2018-08-14
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 Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL | Following 90 days of treatment | The percentages of treated subjects that had 24-hour serum testosterone (T) average concentrations (Cavg) between 300 and 1000 ng/dL |
| Secondary | % of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90 | 90 days | Percentage of Oral TU treated patients who reached study day 90 and had a maximum serum T concentrations (Cmax) values greater than 1500 ng/dL(objective to meet \<15%). |
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 Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL | Following 90 days of treatment | Intent to treat population | percentage of partipants | GEOMETRIC_MEAN |
| SECONDARY | % of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90 | 90 days | Percent of oral TU treated subjects with Cmax \>1500 ng/dL at Study Day 90 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL | Oral Testosterone Undecanoate (TU) | 83.6 | 95% Confidence Interval 76.5 to 89.2 | percentage of partipants | |
| Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL | Topical Testosterone Gel | 79.2 | 95% Confidence Interval 71.8 to 85.4 | percentage of partipants | |
| % of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90 | Oral Testosterone Undecanoate (TU) | 61 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Testosterone Undecanoate (TU) | 161 | |
| Overall Study | STARTED | Topical Testosterone Gel | 160 | |
| Overall Study | Randomized | Oral Testosterone Undecanoate (TU) | 162 | |
| Overall Study | Randomized | Topical Testosterone Gel | 163 | |
| Overall Study | Randomized in Error/ No Treatment Recvd | Oral Testosterone Undecanoate (TU) | 1 | |
| Overall Study | Randomized in Error/ No Treatment Recvd | Topical Testosterone Gel | 3 | |
| Overall Study | COMPLETED | Oral Testosterone Undecanoate (TU) | 129 | |
| Overall Study | COMPLETED | Topical Testosterone Gel | 133 | |
| Overall Study | NOT COMPLETED | Oral Testosterone Undecanoate (TU) | 32 | |
| Overall Study | NOT COMPLETED | Topical Testosterone Gel | 27 |
Source ClinicalTrials.gov
Adverse events90
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 | Polycythaemia | Blood and lymphatic system disorders | Oral Testosterone Undecanoate (TU) | 13 | 161 | |
| other | Polycythaemia | Blood and lymphatic system disorders | Topical Testosterone Gel | 6 | 160 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Oral Testosterone Undecanoate (TU) | 5 | 161 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Topical Testosterone Gel | 0 | 160 | |
| other | Diarrhea | Gastrointestinal disorders | Oral Testosterone Undecanoate (TU) | 9 | 161 | |
| other | Diarrhea | Gastrointestinal disorders | Topical Testosterone Gel | 3 | 160 | |
| other | Eructation | Gastrointestinal disorders | Oral Testosterone Undecanoate (TU) | 4 | 161 | |
| other | Eructation | Gastrointestinal disorders | Topical Testosterone Gel | 0 | 160 | |
| other | Nausea | Gastrointestinal disorders | Oral Testosterone Undecanoate (TU) | 4 | 161 | |
| other | Nausea | Gastrointestinal disorders | Topical Testosterone Gel | 4 | 160 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Testosterone Undecanoate (TU) | 0 | 161 |
| Total, all-cause mortality | Topical Testosterone Gel | 0 | 160 |
| Total, other adverse events | Oral Testosterone Undecanoate (TU) | 110 | 161 |
| Total, other adverse events | Topical Testosterone Gel | 82 | 160 |
| Total, serious adverse events | Oral Testosterone Undecanoate (TU) | 11 | 161 |
| Total, serious adverse events | Topical Testosterone Gel | 6 | 160 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36272969 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Testosterone Undecanoate (TU) vs Topical Testosterone Gel: deaths from any cause | Trial comparisons |
| Oral Testosterone Undecanoate (TU) vs Topical Testosterone Gel: serious adverse events | 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/NCT01403116
GET https://conductscience.org/api/trials/v1/NCT01403116/events?page=2