TESTIM (testosterone)
Testim is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. This includes primary hypogonadism (testicular failure due to conditions such as Klinefelter’s syndrome, chemotherapy, or toxic damage) and hypogonadotropic hypogonadism (congenital or acquired deficiency of gonadotropins or LHRH, or pituitary-hypothalamic injury). **Limitations of Use:** Safety and efficacy have not been established in males with "age-related hypogonadism" or in patients under 18 years of age.
How TESTIM Works
Testim delivers exogenous testosterone, which acts as a replacement for deficient endogenous testosterone. Testosterone and its active metabolite, dihydrotestosterone (DHT), bind to specific receptors in target tissues to promote the growth and development of male sex organs (prostate, penis, scrotum) and the maintenance of secondary sex characteristics. These effects include male-pattern hair distribution, laryngeal enlargement, vocal cord thickening, and the development of male body musculature and fat distribution.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2002-10-31
- Routes
- TRANSDERMAL
- Dosage Forms
- GEL
TESTIM Approval History
What TESTIM Treats
1 indicationsTESTIM is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypogonadism
TESTIM Boxed Warning
SECONDARY EXPOSURE TO TESTOSTERONE Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )] . Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )]. Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Admi...
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )] . Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )]. Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), and Patient Counseling Information ( 17 )]. WARNING: SECONDARY EXPOSURE TO TESTOSTERONE See full prescribing information for complete boxed warning. Virilization has been reported in children who were secondarily exposed to testosterone gel ( 5.1 , 6.2 ) Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel ( 2.2 , 5.1 ) Healthcare providers should advise patients to strictly adhere to recommended instructions for use ( 2.2 , 5.1 , 17 )
TESTIM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
50 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04675788 | 2005890134 1R01HL153114-01 | Ph 4 | completed | Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening |
| NCT07254429 COMPASS | 2025-522558-37-00 2025-522558-37-00 | Ph 2 | recruiting | COMPASS - COpenhagen MenoPAuSe Study |
| NCT01894308 PARC-T-D | PARC-Testosterone-D1/09/13 2013-001766-42, IRAS project ID: 146877 | Ph 2 | not yet recruiting | A Dose Ranging Study to Examine TDS-Testosterone 5% |
| NCT04456296 results posted | EN3000-101 | Ph 4 | completed | A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism |
| NCT02938923 STEP-HI results posted | R01AG051647 201609077 | Ph 3 | completed | Starting a Testosterone and Exercise Program After Hip Injury |
| NCT01573442 results posted | A221102 CDR0000730083, NCI-2012-00719 | Ph 3 | completed | Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment |
| NCT02990533 GRAMS | 16-0146 | Ph 1 | completed | Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients |
| NCT02873559 PROGRESS | Ethical protocol H-16020521 | Ph 2, Ph 3 | completed | Effect of PROGRESSive Training and Teststerone in Older Frail Men |
| NCT06300866 | CRO-2020-04-PGN-LLU-YPZ | Ph 3 | completed | Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste |
| NCT01460654 results posted | MGH-988 | Ph 2 | terminated | Testosterone and Alendronate in Hypogonadal Men |
| NCT01127659 results posted | NIH testosterone grant R01DK075877 | Ph 4 | completed | Testosterone Replacement in Men With Diabetes and Obesity |
| NCT02367105 LITROS results posted | ENDA-034-12F CX000906 | Ph 3 | completed | Lifestyle Intervention and Testosterone Replacement in Obese Seniors |
| NCT01595581 TACL results posted | HS-11-00649 | Ph 3 | completed | Testosterone Administration and ACL Reconstruction in Men |
| NCT02433730 | 22102014 | Ph 4 | completed | Testosterone Therapy in Hypogonadal Men Treated With Opioids |
| NCT01121211 results posted | 2009P-001845/1 5R01MH083657-05A2 | Ph 2 | completed | Hormonal Factors in the Treatment of Anorexia Nervosa |
| NCT02419105 T&D | T&D Study 32003B_135192, SNCTP: 000001224 | Ph 3 | terminated | Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors |
| NCT02991209 Einstein | 010815Testis | Ph 2, Ph 3 | completed | Study of Testosterone vs Placebo in Testicular Cancer Survivors |
| NCT02611154 Intranasal results posted | 84225 | Ph 4 | completed | Intranasal Delivery of Testosterone and Its Effect on Doping Markers |
| NCT02803073 | L16-116 | Ph 2, Ph 3 | withdrawn | Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After a Recent Myocardial Infarction |
| NCT03091348 results posted | MHB023 | Ph 4 | completed | Subcutaneous vs. Intramuscular Testosterone |
| NCT01155518 results posted | 1-10-JF-13 | Ph 2 | terminated | Hypogonadism in Young Men With Type 2 Diabetes |
| NCT02513940 results posted | 1507526854 | Ph 4 | completed | Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes |
| NCT01862835 | 13-000047 | Ph 1 | completed | Impact of Estradiol Addback |
| NCT03967964 | PKAVD+T EC1503 | Ph 1 | completed | Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA) |
| NCT02712944 | L16-079 | Ph 1 | terminated | Testosterone Replacement in Renal Failure |
| NCT01084369 | Testosterone version1 | Ph 4 | terminated | Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism |
| NCT02203656 PACE | 13-038 1229 | Ph 1 | completed | Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults |
| NCT03167541 results posted | RB9-UK-1514 | Ph 1 | completed | Naproxen Sodium (2 x 220 mg) Fasted Comparative Bioavailability Study |
| NCT02799277 PSY | 2014-12-0010 | Ph 4 | completed | A Multinomial Process Model of Moral Judgment |
| NCT03619330 | TESTOSTERON | Ph 4 | completed | Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism. |
| NCT01446042 results posted | TBS-1-2011-03 | Ph 3 | completed | Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism |
| NCT00891228 CCN007 results posted | CCN007 | Ph 1 | completed | Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men |
| NCT00647868 | Nasobol 01/2008 | Ph 1 | completed | NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers |
| NCT01797718 CDGP | EudraCT:2012-002477-59 | Ph 2, Ph 3 | completed | Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment |
| NCT01469988 VITA-HF | 82-VH-01 | Ph 2 | terminated | The VO2 Increase With Testosterone Addition - Heart Failure (VITA-HF) Trial |
| NCT03118479 | 2009 - P - 001874 | Ph 1 | terminated | Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH) |
| NCT00965341 results posted | 2008-0262 | Ph 3 | completed | Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients |
| NCT01961336 | UHR-9 | Ph 3 | completed | Transdermal Testosterone Pretreatment in Poor Responders Undergoing IVF |
| NCT01616732 | 04495 | Ph 2 | completed | Testosterone and Weight Loss |
| NCT01386606 results posted | ZA-204 | Ph 2 | completed | The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone) |
| NCT01725451 results posted | 15083 I5E-MC-TSBD | Ph 1 | completed | A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants |
| NCT01160328 | 09-000309 R01DK045343 | Ph 1 | completed | Influence of Male Hormones on Regional Fat Metabolism |
| NCT02111434 | GSM-022014 | Ph 4 | completed | Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment |
| NCT02111473 | GSM-032014 | Ph 4 | completed | The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism |
| NCT01743235 | EB90 EB90 | Ph 2 | completed | Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems |
| NCT01310647 FOLLPRIM | 2009-018009-26 2009-018009-26 | Ph 2 | completed | Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders |
| NCT01560546 | 2011-002102-73 | Ph 4 | completed | Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) |
| NCT01432665 | EB82 | Ph 2 | completed | Lybrido for Female Sexual Dysfunction |
| NCT00957034 CORDELIA results posted | 2009015 | Ph 2 | terminated | Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure |
| NCT00663793 ORAL-T-6 results posted | 33738-B U54HD42456-06, K23HD045386 | Ph 1 | completed | ORAL T-6: Oral Androgens in Man-6 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TESTIM FDA Label Details
Indications & Usage
FDA Label (PDF)TESTIM is indicated for the treatment of Hypogonadism.
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )] . Children should avoid contact with unwashed or unclothed application sites in men using testo...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment