Trial · NCT01699178

Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men

NCT01699178, Phase 3, Completed, Clarus Therapeutics, Inc.; results first posted 2018-10-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men. Trials, record NCT01699178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01699178

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Trial

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

Title: Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
NCT number: NCT01699178
Status: Completed
Phases: Phase 3
Enrollment: 182 participants, actual
Lead sponsor: Clarus Therapeutics, Inc.
Conditions: Male Hypogonadism
Interventions: Oral testosterone undecanoate, Transdermal testosterone gel (AndroGel)
First posted: 2012-10-03
Last updated: 2021-06-28
Results first posted: 2018-10-30

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Absolute Change From Baseline in T Cholesterol	Approximately 365 days	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Primary	Absolute Change From Baseline in HDL	Approximately 365 days	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Primary	Absolute Change From Baseline in LDL	Approximately 365 days	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Primary	Absolute Change From Baseline in Hgb	Approximately 365 days	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Primary	Absolute Change From Baseline in Hct	Approximately 365 days	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.
Primary	Absolute Change From Baseline in Prostate Volume	Approximately 365 days	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.

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	Absolute Change From Baseline in T Cholesterol	Approximately 365 days	The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.	mg/dL	MEAN
PRIMARY	Absolute Change From Baseline in HDL	Approximately 365 days	The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.	mg/dL	MEAN
PRIMARY	Absolute Change From Baseline in LDL	Approximately 365 days	The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.	mg/dL	MEAN
PRIMARY	Absolute Change From Baseline in Hgb	Approximately 365 days	The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.	g/dL	MEAN
PRIMARY	Absolute Change From Baseline in Hct	Approximately 365 days	The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.	percent	MEAN
PRIMARY	Absolute Change From Baseline in Prostate Volume	Approximately 365 days	The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.	cc	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
Absolute Change From Baseline in T Cholesterol	Oral TU	0.2	95% Confidence Interval -8.4 to 8.9	mg/dL
Absolute Change From Baseline in T Cholesterol	Transdermal T-gel	8.2	95% Confidence Interval -0.1 to 16.6	mg/dL
Absolute Change From Baseline in HDL	Oral TU	2.4	95% Confidence Interval 0.7 to 4.1	mg/dL
Absolute Change From Baseline in HDL	Transdermal T-gel	4.0	95% Confidence Interval 2.5 to 5.5	mg/dL
Absolute Change From Baseline in LDL	Oral TU	-1.5	95% Confidence Interval -9.5 to 6.5	mg/dL
Absolute Change From Baseline in LDL	Transdermal T-gel	6.0	95% Confidence Interval -1.2 to 13.1	mg/dL
Absolute Change From Baseline in Hgb	Oral TU	0.36	95% Confidence Interval 0.11 to 0.61	g/dL
Absolute Change From Baseline in Hgb	Transdermal T-gel	0.36	95% Confidence Interval 0.07 to 0.65	g/dL
Absolute Change From Baseline in Hct	Oral TU	0.38	95% Confidence Interval -0.30 to 1.06	percent
Absolute Change From Baseline in Hct	Transdermal T-gel	0.37	95% Confidence Interval -0.44 to 1.19	percent

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	Oral Testosterone Undecanoate	88
Overall Study	STARTED	Transdermal Testosterone Gel (AndroGel)	94
Overall Study	COMPLETED	Oral Testosterone Undecanoate	69
Overall Study	COMPLETED	Transdermal Testosterone Gel (AndroGel)	62
Overall Study	NOT COMPLETED	Oral Testosterone Undecanoate	19
Overall Study	NOT COMPLETED	Transdermal Testosterone Gel (AndroGel)	32

Source ClinicalTrials.gov

Adverse events58

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	Polycythemia	Blood and lymphatic system disorders	Oral TU	5	88	5
other	Polycythemia	Blood and lymphatic system disorders	Transdermal T-gel	5	94	5
other	Bronchitis	Infections and infestations	Oral TU	4	88	4
other	Bronchitis	Infections and infestations	Transdermal T-gel	4	94	4
other	Sinusitis	Infections and infestations	Oral TU	4	88	4
other	Sinusitis	Infections and infestations	Transdermal T-gel	0	94	0
other	Blood triglycerides increased	Investigations	Oral TU	0	88	0
other	Blood triglycerides increased	Investigations	Transdermal T-gel	2	94	2
other	Hematocrit Increased	Investigations	Oral TU	4	88	4
other	Hematocrit Increased	Investigations	Transdermal T-gel	2	94	2

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oral TU	0	88
Total, all-cause mortality	Transdermal T-gel	0	94
Total, other adverse events	Oral TU	32	88
Total, other adverse events	Transdermal T-gel	33	94
Total, serious adverse events	Oral TU	6	88
Total, serious adverse events	Transdermal T-gel	6	94

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36272969	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 comparisons2

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

Comparison	Source
Oral TU vs Transdermal T-gel: deaths from any cause	Trial comparisons
Oral TU vs Transdermal T-gel: 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.

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/NCT01699178

GET https://conductscience.org/api/trials/v1/NCT01699178/events?page=2

API reference For AI assistants