Trial · NCT02722278
A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
NCT02722278, Phase 3, Completed, Clarus Therapeutics, Inc.; results first posted 2018-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men. Trials, record NCT02722278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02722278
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
- NCT number
- NCT02722278
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 222 participants, actual
- Lead sponsor
- Clarus Therapeutics, Inc.
- Conditions
- Hypogonadism
- Interventions
- Oral Testosterone Undecanoate, Axiron Testosterone Topical Solution
- First posted
- 2016-03-29
- Last updated
- 2018-02-23
- Results first posted
- 2018-02-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7 | Day 105 | |
| Other | Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8 | Approximately 4.5 months | Compare the Oral TU-treated subjects and the Topical Axiron®-treated subjects with respect to number of subjects in the cosyntropin stimulation test substudy with a normal maximum post-stimulation (cosyntropin stimulation) cortisol level at Visit 8. |
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 | Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7 | Day 105 | Intent-to-treat study population All subjects randomized to either Oral TU or Axiron | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8 | Approximately 4.5 months | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7 | Oral Testosterone Undecanoate | 145 | Participants | ||
| Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7 | Axiron Testosterone Topical Solution | 48 | Participants | ||
| Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8 | Oral TU Cosyntropin Substudy Subjects | 19 | Participants | ||
| Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8 | Axiron Cosyntropin Substudy Subjects | 8 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Testosterone Undecanoate | 166 | |
| Overall Study | STARTED | Axiron Testosterone Topical Solution | 56 | |
| Overall Study | COMPLETED | Oral Testosterone Undecanoate | 154 | |
| Overall Study | COMPLETED | Axiron Testosterone Topical Solution | 49 | |
| Overall Study | NOT COMPLETED | Oral Testosterone Undecanoate | 12 | |
| Overall Study | NOT COMPLETED | Axiron Testosterone Topical Solution | 7 |
Source ClinicalTrials.gov
Adverse events120
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 | High Density Lipoprotein Decreased | Investigations | Oral Testosterone Undecanoate | 5 | 166 | 5 |
| other | High Density Lipoprotein Decreased | Investigations | Axiron Testosterone Topical Solution | 0 | 55 | 0 |
| other | Blood triglycerides increased | Investigations | Oral Testosterone Undecanoate | 1 | 166 | 1 |
| other | Blood triglycerides increased | Investigations | Axiron Testosterone Topical Solution | 0 | 55 | 0 |
| other | Blood pressure increased | Investigations | Oral Testosterone Undecanoate | 2 | 166 | 2 |
| other | Blood pressure increased | Investigations | Axiron Testosterone Topical Solution | 1 | 55 | 1 |
| other | Prostatic specific antigen increased | Investigations | Oral Testosterone Undecanoate | 2 | 166 | 2 |
| other | Prostatic specific antigen increased | Investigations | Axiron Testosterone Topical Solution | 0 | 55 | 0 |
| other | Nausea | Gastrointestinal disorders | Oral Testosterone Undecanoate | 4 | 166 | 4 |
| other | Nausea | Gastrointestinal disorders | Axiron Testosterone Topical Solution | 0 | 55 | 0 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Testosterone Undecanoate | 0 | 166 |
| Total, all-cause mortality | Axiron Testosterone Topical Solution | 0 | 56 |
| Total, other adverse events | Oral Testosterone Undecanoate | 31 | 166 |
| Total, other adverse events | Axiron Testosterone Topical Solution | 8 | 55 |
| Total, serious adverse events | Oral Testosterone Undecanoate | 2 | 166 |
| Total, serious adverse events | Axiron Testosterone Topical Solution | 0 | 55 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Testosterone Undecanoate vs Axiron Testosterone Topical Solution: Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7 | Trial comparisons |
| Oral TU Cosyntropin Substudy Subjects vs Axiron Cosyntropin Substudy Subjects: Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8 | Trial comparisons |
| Oral Testosterone Undecanoate vs Axiron Testosterone Topical Solution: deaths from any cause | Trial comparisons |
| Oral Testosterone Undecanoate vs Axiron Testosterone Topical Solution: 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/NCT02722278
GET https://conductscience.org/api/trials/v1/NCT02722278/events?page=2