Testosterone clinical trials
Testosterone is named as an intervention in 8 current clinical trials in our Denmark, UK, China, Netherlands, Belgium, Switzerland and Canada registers. 6 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Transdermal Delivery Solutions Corp (1). The most-studied condition is Klinefelter Syndrome. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Testosterone is approved
All regulators →Of the three regulators tracked here, the first to approve Testosterone was the US, on 12 Oct 1993. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Testosterone patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Testosterone, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 17 Mar 2034 (US 11744838).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Testosterone
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Testosterone works
All drug targets →- Androgen Receptor agonist AgonistTarget: AR androgen receptor✓ In ChEMBL and the Guide to Pharmacology
- Alzheimer diseasePhase 3
- FatiguePhase 3
- InfertilityPhase 3
- Insulin resistancePhase 3
- CancerPhase 3
- Chronic kidney diseasePhase 3
- Coronary artery disorderPhase 3
- Erectile dysfunctionPhase 3
- Hip fracturePhase 3
- MenopausePhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL386630, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 2858, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Testosterone
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 7 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Testosterone
- ATC code
- G03BA03
- ChEMBL
- CHEMBL386630
- DrugBank
- DB00624
- PubChem CID
- 6013
- CAS number
- 58-22-0
- FDA UNII
- 3XMK78S47O
- Wikidata
- Q1318776
- Wikipedia
- Testosterone
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Testosterone
8 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Testosterone in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Testosterone. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Prevention of Sexual Offending with Cognitive Behavioral Therapy Alone Versus Therapy Combined with Testosterone Suppression – the PREVENT-MED randomized clinical trial
2024-518120-68-01 · CTIS ↗ · Mental Disorders
|
Phase 2 | Authorised | Vaestra Goetalandsregionen | Sweden |
Testosterone across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
7 single-substance products containing Testosterone on the HPRA medicines list.
- Testarzon 20 mg/g Transdermal gelAndrolabs · PA25692/001/001 · Marketed
- Testogel 16.2 mg/g, GelLaboratoires Besins International · PA1054/002/004 · Marketed
- Testogel 40.5 mg transdermal gel in sachetLaboratoires Besins International · PA1054/002/005 · Marketed
- Testogel 50 mg transdermal gel in sachetLaboratoires Besins International · PA1054/002/002 · Marketed
- Tostran 20 mg/g transdermal gelAdvanz Pharma Limited · PA23450/002/001 · Marketed
Supply shortages
No entry for Testosterone in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- TestosteroneFDA · 23 Sep 2019 · Generic (ANDA) · Twi Pharms
Conditions studied with Testosterone
15 conditionsAll 15 conditions
| Condition (as registered) | Trials |
|---|---|
| Klinefelter Syndrome | 2 |
| Hypogonadotropism | 1 |
| Transgender | 1 |
| Gender Incongruence | 1 |
| Prostatic Neoplasms | 1 |
| Hypogonadism | 1 |
| Testosterone Deficiency | 1 |
| Hypotestosteronism | 1 |
| Palliative Care | 1 |
| Menopausal Osteoporosis | 1 |
| Bone Markers | 1 |
| Cerebral Blood Flow | 1 |
| Cerebral Blood Flow Regulation | 1 |
| Sex Differences | 1 |
| Exercise | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Transdermal Delivery Solutions Corp | 1 |
| Peking University Third Hospital | 1 |
| Canisius-Wilhelmina Hospital | 1 |
| Jules Bordet Institute | 1 |
| Lise Aksglæde | 1 |
| Martin Blomberg Jensen | 1 |
| Georgios Papadakis | 1 |
| University of British Columbia | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Testosterone trials
How many clinical trials are testing Testosterone?
8 current trials in our Denmark, UK, China, Netherlands, Belgium, Switzerland and Canada registers name Testosterone (also registered as Sustanon 250) as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.
Are Testosterone trials recruiting patients?
Yes. 6 of the 8 trials are recruiting: 2 with sites in Denmark, 1 with sites in China, 1 with sites in Netherlands, 1 with sites in Belgium and 1 with sites in Switzerland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Testosterone clinical trials?
Transdermal Delivery Solutions Corp (1), Peking University Third Hospital (1), Canisius-Wilhelmina Hospital (1) and Jules Bordet Institute (1), among 8 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Testosterone licensed in Ireland?
Yes. The HPRA medicines list includes 7 single-substance products containing Testosterone, for example Testarzon 20 mg/g Transdermal gel (Androlabs). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Testosterone shortage?
Not in the lists we track: Testosterone has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Testosterone works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Testosterone works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Testosterone (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.