Trial · NCT01446042

Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism

NCT01446042, Phase 3, Completed, Acerus Pharmaceuticals Corporation; results first posted 2018-06-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism. Trials, record NCT01446042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01446042

On this page

Trial

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

Title: Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
NCT number: NCT01446042
Status: Completed
Phases: Phase 3
Enrollment: 306 participants, actual
Lead sponsor: Acerus Pharmaceuticals Corporation
Conditions: Male Hypogonadism
Interventions: Testosterone, Testosterone
First posted: 2011-10-04
Last updated: 2018-06-13
Results first posted: 2018-06-13

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Serum Testosterone Cavg	90 days	The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)
Secondary	Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90	90 days	To determine the efficacy of 4.5% TBS-1 gel, administered 2 or 3 times daily at a dose of 5.5 mg per nostril, in achieving the following serum total testosterone maximum concentration (Cmax) on Day 90: * A Cmax (maximum testosterone concentration) value of 1500 ng/dL or more in at least 85% of the participants analyzed * A Cmax (maximum testosterone concentration) value of 1800 to 2500 ng/dL in fewer than 5% of participants analyzed * No analyzed participants with a Cmax (maximum testosterone concentration) \>2500 ng/dL

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	Serum Testosterone Cavg	90 days	Per-Protocol Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90	90 days	ITT subjects who have a Cmax value at the specified visit.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Units
Serum Testosterone Cavg	TBS-1 - b.i.d.		76	Participants
Serum Testosterone Cavg	TBS-1 - b.i.d./t.i.d.		43	Participants
Serum Testosterone Cavg	TBS-1 - t.i.d.		61	Participants
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90	TBS-1 - b.i.d.	Cmax <=1500 ng/dL	107	Participants
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90	TBS-1 - b.i.d./t.i.d.	Cmax <=1500 ng/dL	77	Participants
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90	TBS-1 - t.i.d.	Cmax <=1500 ng/dL	58	Participants
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90	TBS-1 - b.i.d.	1800 ng/dL <= Cmax <=2500 ng/dL	6	Participants
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90	TBS-1 - b.i.d./t.i.d.	1800 ng/dL <= Cmax <=2500 ng/dL	2	Participants
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90	TBS-1 - t.i.d.	1800 ng/dL <= Cmax <=2500 ng/dL	1	Participants
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90	TBS-1 - b.i.d.	Cmax >2500 ng/dL	1	Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	TBS-1 - b.i.d.	142
Overall Study	STARTED	TBS-1 b.i.d./t.i.d	86
Overall Study	STARTED	TBS-1 - t.i.d.	78
Overall Study	COMPLETED	TBS-1 - b.i.d.	122
Overall Study	COMPLETED	TBS-1 b.i.d./t.i.d	83
Overall Study	COMPLETED	TBS-1 - t.i.d.	69
Overall Study	NOT COMPLETED	TBS-1 - b.i.d.	20
Overall Study	NOT COMPLETED	TBS-1 b.i.d./t.i.d	3
Overall Study	NOT COMPLETED	TBS-1 - t.i.d.	9

Source ClinicalTrials.gov

Adverse events111

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	Retching	Gastrointestinal disorders	TBS-1 - b.i.d.	0	142
other	Retching	Gastrointestinal disorders	TBS-1 - b.i.d./t.i.d.	2	86
other	Retching	Gastrointestinal disorders	TBS-1 - t.i.d.	0	78
other	Nausea	Gastrointestinal disorders	TBS-1 - b.i.d.	1	142
other	Nausea	Gastrointestinal disorders	TBS-1 - b.i.d./t.i.d.	1	86
other	Nausea	Gastrointestinal disorders	TBS-1 - t.i.d.	2	78
other	Chills	General disorders	TBS-1 - b.i.d.	0	142
other	Chills	General disorders	TBS-1 - b.i.d./t.i.d.	1	86
other	Chills	General disorders	TBS-1 - t.i.d.	2	78
other	Pyrexia	General disorders	TBS-1 - b.i.d.	0	142

1 to 10 of 111Source ClinicalTrials.gov

See all 111 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TBS-1 - b.i.d.	0	142
Total, all-cause mortality	TBS-1 - b.i.d./t.i.d.	0	86
Total, all-cause mortality	TBS-1 - t.i.d.	1	78
Total, other adverse events	TBS-1 - b.i.d.	65	142
Total, other adverse events	TBS-1 - b.i.d./t.i.d.	40	86
Total, other adverse events	TBS-1 - t.i.d.	46	78
Total, serious adverse events	TBS-1 - b.i.d.	2	142
Total, serious adverse events	TBS-1 - b.i.d./t.i.d.	1	86
Total, serious adverse events	TBS-1 - t.i.d.	2	78

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26695758	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/NCT01446042

GET https://conductscience.org/api/trials/v1/NCT01446042/events?page=2

API reference For AI assistants