Trial · NCT01270841

Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

NCT01270841, Phase 2, Completed, Repros Therapeutics Inc.; results first posted 2014-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism. Trials, record NCT01270841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01270841

On this page

Trial

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

Title: Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
NCT number: NCT01270841
Status: Completed
Phases: Phase 2
Enrollment: 83 participants, actual
Lead sponsor: Repros Therapeutics Inc.
Conditions: Secondary Hypogonadism
Interventions: Placebo, topical testosterone, Androxal
First posted: 2011-01-05
Last updated: 2014-07-28
Results first posted: 2014-07-28

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Change in Total Morning Testosterone	3 months	Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim
Secondary	Change in Luteinizing Hormone Levels	3 months	Changes in values from baseline in LH at month 3
Secondary	Change in FSH After 3 Months of Treatment	3 months
Secondary	Reproductive Safety	3 months	Change from baseline in sperm concentration

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Total Morning Testosterone	3 months	Intent to treat subjects with an assessment after baseline	ng/dL	MEAN
SECONDARY	Change in Luteinizing Hormone Levels	3 months	ITT population	mIU/mL	MEAN
SECONDARY	Change in FSH After 3 Months of Treatment	3 months	ITT population	mIU/mL	MEAN
SECONDARY	Reproductive Safety	3 months	Subjects with end of study assessments	millions/mL	MEAN

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Value	Spread	Units
Change in Total Morning Testosterone	Placebo	-16.9	Standard Deviation 47.5	ng/dL
Change in Total Morning Testosterone	Testim (Topical Testosterone)	253.7	Standard Deviation 292.3	ng/dL
Change in Total Morning Testosterone	Androxal 12.5 mg	258.5	Standard Deviation 201.5	ng/dL
Change in Total Morning Testosterone	Androxal 25 mg	197.3	Standard Deviation 162.6	ng/dL
Change in Luteinizing Hormone Levels	Placebo	-0.1	Standard Deviation 1.0	mIU/mL
Change in Luteinizing Hormone Levels	Testim (Topical Testosterone)	-2.4	Standard Deviation 2.4	mIU/mL
Change in Luteinizing Hormone Levels	Androxal 12.5 mg	4.8	Standard Deviation 4.7	mIU/mL
Change in Luteinizing Hormone Levels	Androxal 25 mg	6.9	Standard Deviation 7.7	mIU/mL
Change in FSH After 3 Months of Treatment	Placebo	-0.2	Standard Deviation 0.7	mIU/mL
Change in FSH After 3 Months of Treatment	Testim (Topical Testosterone)	-4.4	Standard Deviation 2.9	mIU/mL

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	29
Overall Study	STARTED	Testim (Topical Testosterone)	33
Overall Study	STARTED	Androxal 12.5 mg	29
Overall Study	STARTED	Androxal 25 mg	33
Overall Study	COMPLETED	Placebo	16
Overall Study	COMPLETED	Testim (Topical Testosterone)	19
Overall Study	COMPLETED	Androxal 12.5 mg	18
Overall Study	COMPLETED	Androxal 25 mg	20
Overall Study	NOT COMPLETED	Placebo	13
Overall Study	NOT COMPLETED	Testim (Topical Testosterone)	14

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events28

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	Placebo	0	28
other	Nausea	Gastrointestinal disorders	Testim (Topical Testosterone)	1	33
other	Nausea	Gastrointestinal disorders	Androxal 12.5 mg	1	27
other	Nausea	Gastrointestinal disorders	Androxal 25 mg	2	33
other	Diarrhea	Gastrointestinal disorders	Placebo	1	28
other	Diarrhea	Gastrointestinal disorders	Testim (Topical Testosterone)	1	33
other	Diarrhea	Gastrointestinal disorders	Androxal 12.5 mg	2	27
other	Diarrhea	Gastrointestinal disorders	Androxal 25 mg	1	33
other	Addominal Pain Upper	Gastrointestinal disorders	Placebo	2	28
other	Addominal Pain Upper	Gastrointestinal disorders	Testim (Topical Testosterone)	1	33

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Testim (Topical Testosterone)
Total, all-cause mortality	Androxal 12.5 mg
Total, all-cause mortality	Androxal 25 mg
Total, other adverse events	Placebo	3	28
Total, other adverse events	Testim (Topical Testosterone)	15	33
Total, other adverse events	Androxal 12.5 mg	3	27
Total, other adverse events	Androxal 25 mg	3	33
Total, serious adverse events	Placebo	0	28
Total, serious adverse events	Testim (Topical Testosterone)	1	33

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25044085	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 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/NCT01270841

GET https://conductscience.org/api/trials/v1/NCT01270841/events?page=2

API reference For AI assistants