Trial · NCT01532414
Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism
NCT01532414, Phase 3, Completed, Repros Therapeutics Inc.; results first posted 2015-05-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism. Trials, record NCT01532414. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01532414
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism
- NCT number
- NCT01532414
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 151 participants, actual
- Lead sponsor
- Repros Therapeutics Inc.
- Conditions
- Secondary Hypogonadism
- Interventions
- Androxal, Placebo
- First posted
- 2012-02-14
- Last updated
- 2015-05-27
- Results first posted
- 2015-05-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range | 3 months | Proportion of pooled Androxal subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg will be calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing. If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the co-primary endpoint based on the Cavg for testosterone has been achieved. FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated. |
| Primary | Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm | 3 months | Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo. The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations. |
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 | Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range | 3 months | ITT population. | Percentage of Subjects | NUMBER |
| PRIMARY | Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm | 3 months | ITT. | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range | Androxal Treated Subjects Pooled | 78.8 | 95% Confidence Interval 70.3 to 85.3 | Percentage of Subjects | |
| Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm | Androxal Subjects Pooled | 14.2 | percentage of participants | ||
| Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm | Placebo | 2.6 | percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Androxal 12.5 mg | 92 | |
| Overall Study | STARTED | Androxal 25 mg | 21 | |
| Overall Study | STARTED | Placebo | 38 | |
| Overall Study | COMPLETED | Androxal 12.5 mg | 85 | |
| Overall Study | COMPLETED | Androxal 25 mg | 19 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | Androxal 12.5 mg | 7 | |
| Overall Study | NOT COMPLETED | Androxal 25 mg | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events18
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 | Palpitations | Cardiac disorders | Androxal 12.5 mg | 0 | 92 | |
| other | Palpitations | Cardiac disorders | Androxal 25 mg | 1 | 21 | |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 38 | |
| other | Ocular discomfort | Eye disorders | Androxal 12.5 mg | 0 | 92 | |
| other | Ocular discomfort | Eye disorders | Androxal 25 mg | 1 | 21 | |
| other | Ocular discomfort | Eye disorders | Placebo | 0 | 38 | |
| other | Nausea | Gastrointestinal disorders | Androxal 12.5 mg | 0 | 92 | |
| other | Nausea | Gastrointestinal disorders | Androxal 25 mg | 0 | 21 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 38 | |
| other | Upper respiratort tract infection | Infections and infestations | Androxal 12.5 mg | 5 | 92 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Androxal 12.5 mg | ||
| Total, all-cause mortality | Androxal 25 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Androxal 12.5 mg | 5 | 92 |
| Total, other adverse events | Androxal 25 mg | 6 | 21 |
| Total, other adverse events | Placebo | 4 | 38 |
| Total, serious adverse events | Androxal 12.5 mg | 0 | 92 |
| Total, serious adverse events | Androxal 25 mg | 0 | 21 |
| Total, serious adverse events | Placebo | 0 | 38 |
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/NCT01532414
GET https://conductscience.org/api/trials/v1/NCT01532414/registered