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ClinicalTrials.gov public records Last synced Oct 18, 2026, 7:41 AM EDT

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Showing 1–24 of 34 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Testosterone undecanoate Clear all
Completed Phase 3 Interventional Results available

Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

NCT01403116
View directory record Official record
Conditions
Male Hypogonadism
Interventions
Oral testosterone undecanoate, topical testosterone gel
Drug
Lead sponsor
Clarus Therapeutics, Inc.
Industry
Eligibility
18 Years to 75 Years · Male only
Enrollment
325 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
25
States / cities
Birmingham, Alabama • Calera, Alabama • Huntsville, Alabama + 20 more
Source: ClinicalTrials.gov public record
Updated Aug 14, 2018 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men

NCT03198728
View directory record Official record
Conditions
Hypogonadism, Male
Interventions
SOV2012-F1, AndroGel
Drug
Lead sponsor
Marius Pharmaceuticals
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
314 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
36
States / cities
Birmingham, Alabama • Mobile, Alabama • Tucson, Arizona + 31 more
Source: ClinicalTrials.gov public record
Updated Jun 28, 2023 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Phlebotomy Study of Testosterone Undecanoate

NCT02670343
View directory record Official record
Conditions
Hypogonadism
Interventions
Oral Testosterone Undecanoate
Drug
Lead sponsor
Clarus Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
1
States / cities
Torrance, California
Source: ClinicalTrials.gov public record
Updated Mar 9, 2018 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 2 Interventional Results available

Oral Testosterone for the Treatment of Hypogonadism

NCT01717768
View directory record Official record
Conditions
Hypogonadism
Interventions
TSX-002
Drug
Lead sponsor
TesoRx Pharma, LLC
Industry
Eligibility
18 Years and older · Male only
Enrollment
130 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Dec 15, 2015 · Synced Oct 18, 2026, 7:41 AM EDT
Not yet recruiting Phase 2 Interventional Accepts healthy volunteers

An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD

NCT06082817
View directory record Official record
Conditions
Hypoactive Sexual Desire Disorder
Interventions
Oral Testosterone Undecanoate
Drug
Lead sponsor
San Diego Sexual Medicine
Other
Eligibility
21 Years to 75 Years · Female only
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025
U.S. locations
1
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated Nov 13, 2024 · Synced Oct 18, 2026, 7:41 AM EDT
Recruiting Phase 2 Interventional

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

NCT04798469
View directory record Official record
Conditions
Opioid Use, Pain, Hypogonadism, Male
Interventions
Testosterone Undecanoate 250 MG/ML, Placebo
Drug
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
18 Years and older · Male only
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 3 Interventional Results available

A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

NCT02722278
View directory record Official record
Conditions
Hypogonadism
Interventions
Oral Testosterone Undecanoate, Axiron Testosterone Topical Solution
Drug
Lead sponsor
Clarus Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
222 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
1
States / cities
Northbrook, Illinois
Source: ClinicalTrials.gov public record
Updated Feb 23, 2018 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 2 Interventional Results available

Pharmacokinetic Study to Determine Time to Steady-state

NCT00911586
View directory record Official record
Conditions
Male Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
Interventions
Testosterone undecanoate
Drug
Lead sponsor
Clarus Therapeutics, Inc.
Industry
Eligibility
18 Years to 75 Years · Male only
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Dec 11, 2020 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 3 Interventional Results available

Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men

NCT03868059
View directory record Official record
Conditions
Hypogonadism, Male
Interventions
LPCN 1021
Drug
Lead sponsor
Lipocine Inc.
Industry
Eligibility
18 Years to 80 Years · Male only
Enrollment
138 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
16
States / cities
Birmingham, Alabama • Aventura, Florida • Coral Gables, Florida + 13 more
Source: ClinicalTrials.gov public record
Updated Jun 10, 2021 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers

Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration

NCT06393634
View directory record Official record
Conditions
Healthy
Interventions
Testosterone injection, Testosterone gel, Testosterone Oral
Drug
Lead sponsor
Sports Medicine Research and Testing Laboratory
Industry
Eligibility
18 Years to 60 Years · Male only
Enrollment
14 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
1
States / cities
South Jordan, Utah
Source: ClinicalTrials.gov public record
Updated Dec 3, 2024 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes

NCT03973840
View directory record Official record
Conditions
Hypogonadism, Male
Interventions
Testosterone Undecanoate
Drug
Lead sponsor
Clarus Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
13 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
Northbrook, Illinois
Source: ClinicalTrials.gov public record
Updated Jul 9, 2019 · Synced Oct 18, 2026, 7:41 AM EDT
Terminated Phase 2 Interventional Results available

Testosterone Plus Finasteride Treatment After Spinal Cord Injury

NCT02248701
View directory record Official record
Conditions
Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injuries, Central Nervous System Diseases, Nervous System Diseases, Spinal Cord Diseases, Gonadal Disorders, Endocrine System Diseases, Hypogonadism, Genital Diseases, Male
Interventions
Testosterone Enanthate, Finasteride, Placebo injection, Placebo pill
Drug
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
18 Years and older · Male only
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
2
States / cities
Gainesville, Florida • Tampa, Florida
Source: ClinicalTrials.gov public record
Updated Sep 29, 2023 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 2 Interventional Results available

Oral Testosterone for the Treatment of Hypogonadism in Males

NCT02222558
View directory record Official record
Conditions
Hypogonadism
Interventions
TSX-002
Drug
Lead sponsor
TesoRx Pharma, LLC
Industry
Eligibility
18 Years to 70 Years · Male only
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated May 30, 2016 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 4 Interventional Results available

A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism

NCT04456296
View directory record Official record
Conditions
Hypogonadism, Hypogonadism, Male, Hypogonadotropic Hypogonadism
Interventions
Aveed Injectable Product, Fortesta, Testim
Drug
Lead sponsor
Endo USA Inc., a Keenova Therapeutics Company
Industry
Eligibility
18 Years and older · Male only
Enrollment
673 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
35
States / cities
Birmingham, Alabama • Tucson, Arizona • North Little Rock, Arkansas + 27 more
Source: ClinicalTrials.gov public record
Updated Mar 14, 2025 · Synced Oct 18, 2026, 7:41 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer

NCT05081193
View directory record Official record
Conditions
Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Interventions
Testosterone Undecanoate, Enzalutamide
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years and older · Male only
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
2
States / cities
Baltimore, Maryland • Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 29, 2026 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 2 Interventional Results available

The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate

NCT02921386
View directory record Official record
Conditions
Hypogonadism
Interventions
Oral Testosterone Undecanoate
Drug
Lead sponsor
Clarus Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
2
States / cities
Torrance, California • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated May 17, 2018 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 3 Interventional Results available

Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men

NCT04467697
View directory record Official record
Conditions
Hypogonadism, Male
Interventions
SOV2012-F1
Drug
Lead sponsor
Marius Pharmaceuticals
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
155 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
19
States / cities
Birmingham, Alabama • Mobile, Alabama • Aventura, Florida + 16 more
Source: ClinicalTrials.gov public record
Updated Jun 28, 2024 · Synced Oct 18, 2026, 7:41 AM EDT
Recruiting Phase 2 Interventional

Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury

NCT04460872
View directory record Official record
Conditions
Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injury, Central Nervous System Diseases, Spinal Cord Diseases, Gonadal Disorders, Endocrine System Diseases, Hypogonadism, Genital Diseases, Male, Spinal Cord Trauma, Injuries, Spinal Cord, Walking, Difficulty, Gait Disorders, Neurologic, Locomotion Disorder, Neurologic, Wounds and Injuries, Nervous System Diseases, Testosterone Deficiency, Androgen Deficiency, Hormone Deficiency
Interventions
Testosterone Enanthate, Locomotor Training
Drug · Behavioral
Lead sponsor
North Florida Foundation for Research and Education
Other
Eligibility
18 Years and older · Male only
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
2
States / cities
Gainesville, Florida • Jacksonville, Florida
Source: ClinicalTrials.gov public record
Updated May 6, 2025 · Synced Oct 18, 2026, 7:41 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males

NCT03335254
View directory record Official record
Conditions
Hypogonadism, Hypogonadism, Male, Gonadal Disorders, Endocrine System Diseases, Testosterone Deficiency
Interventions
TSX-011
Drug
Lead sponsor
TesoRx Pharma, LLC
Industry
Eligibility
18 Years to 75 Years · Male only
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Glendale, California
Source: ClinicalTrials.gov public record
Updated May 16, 2019 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 2 Interventional Results available

Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

NCT02697188
View directory record Official record
Conditions
Hypogonadism
Interventions
Testosterone undecanoate, Testosterone enanthate
Drug
Lead sponsor
Clarus Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
2
States / cities
Los Angeles, California • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Nov 1, 2018 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 2 Interventional Results available

A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial

NCT04685993
View directory record Official record
Conditions
NASH - Nonalcoholic Steatohepatitis
Interventions
LPCN 1144
Drug
Lead sponsor
Lipocine Inc.
Industry
Eligibility
18 Years to 80 Years · Male only
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
10
States / cities
Roseville, California • Ocoee, Florida • Las Vegas, Nevada + 6 more
Source: ClinicalTrials.gov public record
Updated Jul 17, 2024 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy Trial of Testosterone Undecanoate

NCT01765179
View directory record Official record
Conditions
Male Hypogonadism
Interventions
Oral testosterone undecanoate
Drug
Lead sponsor
Clarus Therapeutics, Inc.
Industry
Eligibility
18 Years to 75 Years · Male only
Enrollment
144 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013
U.S. locations
27
States / cities
Birmingham, Alabama • Huntsville, Alabama • Glendale, Arizona + 22 more
Source: ClinicalTrials.gov public record
Updated Dec 12, 2017 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 2 Interventional Results available

Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

NCT00924612
View directory record Official record
Conditions
Male Hypogonadism
Interventions
Oral testosterone undecanoate (containing 300 mg T)
Drug
Lead sponsor
Clarus Therapeutics, Inc.
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
1
States / cities
Torrance, California
Source: ClinicalTrials.gov public record
Updated Dec 2, 2020 · Synced Oct 18, 2026, 7:41 AM EDT
Completed Phase 2 Interventional Results available

Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men

NCT00695110
View directory record Official record
Conditions
Hypogonadism
Interventions
Oral testosterone undecanoate (TU) (300 mg T equivalents/dose), Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose), Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food), Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)
Drug
Lead sponsor
Clarus Therapeutics, Inc.
Industry
Eligibility
18 Years to 68 Years · Male only
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
4
States / cities
Birmingham, Alabama • Los Angeles, California • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Jun 25, 2021 · Synced Oct 18, 2026, 7:41 AM EDT