Trial · NCT01191320

Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus

NCT01191320, Phase 2, Completed, Repros Therapeutics Inc.; results first posted 2014-07-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus. Trials, record NCT01191320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01191320

On this page

Trial

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

Title: Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
NCT number: NCT01191320
Status: Completed
Phases: Phase 2
Enrollment: 102 participants, actual
Lead sponsor: Repros Therapeutics Inc.
Conditions: Type 2 Diabetes Mellitus, Secondary Hypogonadism
Interventions: Placebo, Androxal
First posted: 2010-08-30
Last updated: 2014-07-24
Results first posted: 2014-07-24

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Change in HbA1C	3 months	The change in HbA1c from Baseline to 3 Months for each treatment arm

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in HbA1C	3 months	ITT population	Ratio	MEAN

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Spread	Units
Change in HbA1C	Placebo	Standard Deviation 0.012	Ratio
Change in HbA1C	Androxal 12.5 mg	Standard Deviation 0.015	Ratio
Change in HbA1C	Androxal 25 mg	Standard Deviation 0.010	Ratio

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	43
Overall Study	STARTED	Androxal 12.5 mg	38
Overall Study	STARTED	Androxal 25 mg	38
Overall Study	COMPLETED	Placebo	36
Overall Study	COMPLETED	Androxal 12.5 mg	32
Overall Study	COMPLETED	Androxal 25 mg	31
Overall Study	NOT COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	Androxal 12.5 mg	6
Overall Study	NOT COMPLETED	Androxal 25 mg	7

Source ClinicalTrials.gov

Adverse events21

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	Sinusitis	Infections and infestations	Placebo	0	43
other	Sinusitis	Infections and infestations	Androxal 12.5 mg	2	38
other	Sinusitis	Infections and infestations	Androxal 25 mg	1	38
other	Glycosylated Hemoglobin increased	Investigations	Placebo	1	43
other	Glycosylated Hemoglobin increased	Investigations	Androxal 12.5 mg	2	38
other	Glycosylated Hemoglobin increased	Investigations	Androxal 25 mg	0	38
other	Muscle spasms	Musculoskeletal and connective tissue disorders	Placebo	0	43
other	Muscle spasms	Musculoskeletal and connective tissue disorders	Androxal 12.5 mg	2	38
other	Muscle spasms	Musculoskeletal and connective tissue disorders	Androxal 25 mg	0	38
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo	0	43

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Androxal 12.5 mg
Total, all-cause mortality	Androxal 25 mg
Total, other adverse events	Placebo	1	43
Total, other adverse events	Androxal 12.5 mg	8	38
Total, other adverse events	Androxal 25 mg	5	38
Total, serious adverse events	Placebo	1	43
Total, serious adverse events	Androxal 12.5 mg	0	38
Total, serious adverse events	Androxal 25 mg	1	38

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/NCT01191320

GET https://conductscience.org/api/trials/v1/NCT01191320/events?page=2

API reference For AI assistants