Trial · NCT01739595

Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism

NCT01739595, 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 Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism. Trials, record NCT01739595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01739595

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism
NCT number: NCT01739595
Status: Completed
Phases: Phase 3
Enrollment: 181 participants, actual
Lead sponsor: Repros Therapeutics Inc.
Conditions: Secondary Hypogonadism
Interventions: enclomiphene citrate, Placebo
First posted: 2012-12-03
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	Subjects With Testosterone in Normal Range After Treatment	3 months	Proportion (percent) of subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg was 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 coprimary endpoint based on the Cavg for testosterone would have 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	Change in Sperm Concentration	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	Subjects With Testosterone in Normal Range After Treatment	3 months	ITT population.	Percentage of Subjects	NUMBER
PRIMARY	Change in Sperm Concentration	3 months	ITT	percentage of subjects	NUMBER

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Subjects With Testosterone in Normal Range After Treatment	Androxal Subjects Pooled	81.3	95% Confidence Interval 73.9 to 87.0	Percentage of Subjects
Change in Sperm Concentration	Androxal Subjects Pooled	14.2		percentage of subjects
Change in Sperm Concentration	Placebo	4.3		percentage of subjects

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Androxal 12.5 mg	112
Overall Study	STARTED	Androxal 25 mg	22
Overall Study	STARTED	Placebo	47
Overall Study	COMPLETED	Androxal 12.5 mg	99
Overall Study	COMPLETED	Androxal 25 mg	21
Overall Study	COMPLETED	Placebo	45
Overall Study	NOT COMPLETED	Androxal 12.5 mg	13
Overall Study	NOT COMPLETED	Androxal 25 mg	1
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events66

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
other	Nausea	Gastrointestinal disorders	Androxal 12.5 mg	4	112
other	Nausea	Gastrointestinal disorders	Androxal 25 mg	1	22
other	Nausea	Gastrointestinal disorders	Placebo	3	47
other	Hiatus hernia	Gastrointestinal disorders	Androxal 12.5 mg	0	112
other	Hiatus hernia	Gastrointestinal disorders	Androxal 25 mg	1	22
other	Hiatus hernia	Gastrointestinal disorders	Placebo	0	47
other	Fatigue	General disorders	Androxal 12.5 mg	2	112
other	Fatigue	General disorders	Androxal 25 mg	1	22
other	Fatigue	General disorders	Placebo	2	47
other	Pyrexia	General disorders	Androxal 12.5 mg	0	112

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse 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	21	112
Total, other adverse events	Androxal 25 mg	16	22
Total, other adverse events	Placebo	10	47
Total, serious adverse events	Androxal 12.5 mg	1	112
Total, serious adverse events	Androxal 25 mg	0	22
Total, serious adverse events	Placebo	0	47

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01739595

GET https://conductscience.org/api/trials/v1/NCT01739595/events?page=2

API reference For AI assistants