Trial · NCT01534208

Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

NCT01534208, Phase 3, Completed, Repros Therapeutics Inc.; results first posted 2014-07-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism. Trials, record NCT01534208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01534208

On this page

Trial

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

Title: Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
NCT number: NCT01534208
Status: Completed
Phases: Phase 3
Enrollment: 499 participants, actual
Lead sponsor: Repros Therapeutics Inc.
Conditions: Secondary Hypogonadism
Interventions: Androxal
First posted: 2012-02-16
Last updated: 2014-07-24
Results first posted: 2014-07-24

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Morning Testosterone at 26 Weeks	6 months	Changes in values from baseline of total morning testosterone levels at Week 26
Primary	Change From Baseline in LH	6 months	Mean change from baseline in LH at end of treatment (26 weeks)
Primary	Absolute Values of Morning Testosterone	6 months	Absolute values of morning testosterone at end of treatment (26 weeks)
Primary	Mean Change From Baseline FPG	6 months	Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)
Primary	Change From Baseline in BMI	6 months	Mean change from baseline in BMI at end of treatment (26 weeks)
Primary	Change From Baseline in FSH	6 months	Change from baseline in FSH at end of treatment (26 weeks)

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	Change From Baseline in Total Morning Testosterone at 26 Weeks	6 months	Intent to Treat population	ng/dL	MEAN
PRIMARY	Change From Baseline in LH	6 months	ITT	mIu/mL	MEAN
PRIMARY	Absolute Values of Morning Testosterone	6 months	ITT	ng/dL	MEAN
PRIMARY	Mean Change From Baseline FPG	6 months		mg/dL	MEAN
PRIMARY	Change From Baseline in BMI	6 months	ITT	kg/m2	MEAN
PRIMARY	Change From Baseline in FSH	6 months		U/L	MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Total Morning Testosterone at 26 Weeks	Androxal 12.5 mg	280.9	Standard Deviation 141.4	ng/dL
Change From Baseline in Total Morning Testosterone at 26 Weeks	Androxal 25 mg	214.7	Standard Deviation 154.7	ng/dL
Change From Baseline in LH	Androxal 12.5 mg	4.81	Standard Deviation 5.69	mIu/mL
Change From Baseline in LH	Androxal 25 mg	4.27	Standard Deviation 4.29	mIu/mL
Absolute Values of Morning Testosterone	Androxal 12.5 mg	511.6	Standard Deviation 140.8	ng/dL
Absolute Values of Morning Testosterone	Androxal 25 mg	416.7	Standard Deviation 154.7	ng/dL
Mean Change From Baseline FPG	Androxal 12.5 mg	-5.4	Standard Deviation 30.8	mg/dL
Mean Change From Baseline FPG	Androxal 25 mg	-5.0	Standard Deviation 29.3	mg/dL
Change From Baseline in BMI	Androxal 12.5 mg	0.2	Standard Deviation 1.4	kg/m2
Change From Baseline in BMI	Androxal 25 mg	0.3	Standard Deviation 1.1	kg/m2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Androxal 12.5 mg	216
Overall Study	STARTED	Androxal 25 mg	283
Overall Study	COMPLETED	Androxal 12.5 mg	159
Overall Study	COMPLETED	Androxal 25 mg	234
Overall Study	NOT COMPLETED	Androxal 12.5 mg	57
Overall Study	NOT COMPLETED	Androxal 25 mg	49

Source ClinicalTrials.gov

Adverse events48

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	Upper respiratory tract infection	Infections and infestations	Androxal 12.5 mg	26	207	26
other	Upper respiratory tract infection	Infections and infestations	Androxal 25 mg	27	283	27
other	Headache	Nervous system disorders	Androxal 12.5 mg	12	207
other	Headache	Nervous system disorders	Androxal 25 mg	23	283
other	Hot flush	General disorders	Androxal 12.5 mg	2	207
other	Hot flush	General disorders	Androxal 25 mg	9	283
other	Influenza	Infections and infestations	Androxal 12.5 mg	7	207
other	Influenza	Infections and infestations	Androxal 25 mg	5	283
other	Sinusitis	Infections and infestations	Androxal 12.5 mg	7	207
other	Sinusitis	Infections and infestations	Androxal 25 mg	6	283

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

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, other adverse events	Androxal 12.5 mg	66	207
Total, other adverse events	Androxal 25 mg	92	283
Total, serious adverse events	Androxal 12.5 mg	6	207
Total, serious adverse events	Androxal 25 mg	9	283

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Androxal 12.5 mg vs Androxal 25 mg: 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.

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/NCT01534208

GET https://conductscience.org/api/trials/v1/NCT01534208/events?page=2

API reference For AI assistants